Trial Outcomes & Findings for Trial of Pregabalin for Granulocyte Colony-stimulating Factor (GCSF)-Induced Bone Pain (NCT NCT03407430)
NCT ID: NCT03407430
Last Updated: 2018-06-26
Results Overview
Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B. The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying "no pain" and 10 signifying "the worst pain you can imagine."
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2018-06-26
Participant Flow
Subjects were recruited from 11/2015 through 07/2017.
Eleven subjects were screened and successfully consented to this trial. Of these, three subjects either had therapy alteration that led to their exclusion or left without study-related medication, thus 8 subjects were treated.
Participant milestones
| Measure |
Pregabalin, Then Placebo
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
Placebo, Then Pregabalin
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|
|
First Intervention
STARTED
|
5
|
3
|
|
First Intervention
COMPLETED
|
5
|
3
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
5
|
3
|
|
Washout
COMPLETED
|
4
|
3
|
|
Washout
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
4
|
3
|
|
Second Intervention
COMPLETED
|
4
|
3
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pregabalin, Then Placebo
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
Placebo, Then Pregabalin
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|
|
Washout
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Trial of Pregabalin for Granulocyte Colony-stimulating Factor (GCSF)-Induced Bone Pain
Baseline characteristics by cohort
| Measure |
Pregabalin, Then Placebo
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
Placebo, Then Pregabalin
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
46.2 years
n=99 Participants
|
51.3 years
n=107 Participants
|
48.1 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Serum creatinine (SCr)
|
0.7 mg/dL
n=99 Participants
|
0.6 mg/dL
n=107 Participants
|
0.7 mg/dL
n=206 Participants
|
|
Baseline pain score
|
0.8 units on a scale
n=99 Participants
|
3.3 units on a scale
n=107 Participants
|
1.8 units on a scale
n=206 Participants
|
|
Body Mass Index (BMI)
|
28.2 kg/m^2
n=99 Participants
|
24.3 kg/m^2
n=107 Participants
|
26.7 kg/m^2
n=206 Participants
|
|
Body Surface Area (BSA)
|
1.89 m^2
n=99 Participants
|
1.86 m^2
n=107 Participants
|
1.88 m^2
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
|
0.4 units on a scale
n=99 Participants
|
0.3 units on a scale
n=107 Participants
|
0.4 units on a scale
n=206 Participants
|
|
Baseline neuropathic pain scale
|
0 units on a scale
n=99 Participants
|
0.3 units on a scale
n=107 Participants
|
0.1 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksCompare the proportion of patients who have an increase in pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B. The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying "no pain" and 10 signifying "the worst pain you can imagine."
Outcome measures
| Measure |
Second Intervention = Placebo
n=3 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Number of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeksCompare the proportion of patients who have an increase in pain score of ≥ 3 from baseline between pregabalin and placebo across the 2 cycles. The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying "no pain" and 10 signifying "the worst pain you can imagine."
Outcome measures
| Measure |
Second Intervention = Placebo
n=4 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Proportion of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Between Pregabalin and Placebo Across the 2 Cycles
|
0.5 proportion
|
0 proportion
|
0 proportion
|
0.333 proportion
|
SECONDARY outcome
Timeframe: Up to 12 weeksCompare the proportion of patients who have an increase in bone/joint pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B. The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying "no pain" and 10 signifying "the worst pain you can imagine."
Outcome measures
| Measure |
Second Intervention = Placebo
n=3 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Proportion of Patients Who Have an Increase in Bone/Joint Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1
|
0 proportion
|
0 proportion
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeksCompare the number of days of breakthrough analgesic use between pregabalin and placebo within cycle 1 and across the 2 cycles. The number of days of breakthrough analgesic use (i.e additional pain medication being required) is evaluated based on participant-provided medication logs kept during study treatment. If additional pain medication outside of their normal pain control regimen was reported, this day counts as 1. The total days for each patient are then reported, with a total range from zero to 14 (for patients with breast cancer) or zero to 21 (for patients with a lymphoma).
Outcome measures
| Measure |
Second Intervention = Placebo
n=4 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Number of Days of Breakthrough Analgesic Use Between Pregabalin and Placebo Across the 2 Cycles
|
3.25 days
Interval 0.0 to 13.0
|
1.4 days
Interval 0.0 to 5.0
|
0.67 days
Interval 0.0 to 1.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksCompare the proportion of patients with severe pain between pregabalin and placebo within cycle 1 and across the 2 cycles. The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying "no pain" and 10 signifying "the worst pain you can imagine."
Outcome measures
| Measure |
Second Intervention = Placebo
n=4 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Proportion of Patients With Severe Pain Between Pregabalin and Placebo Across the 2 Cycles
|
0.25 proportion
|
0.4 proportion
|
0.67 proportion
|
0 proportion
|
SECONDARY outcome
Timeframe: Up to 12 weeksCompare the maximum change in pain score from baseline between pregabalin and placebo within cycle 1 and across the 2 cycles. The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying "no pain" and 10 signifying "the worst pain you can imagine." Each patient will be assessed regularly, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 \& 2), 4 days after pegfilgrastim administration (during cycles 1 \& 2), and 8 days after pegfilgrastim administration (during cycles 1 \& 2).
Outcome measures
| Measure |
Second Intervention = Placebo
n=4 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Maximum Change in Pain Score From Baseline Between Pregabalin and Placebo Across the 2 Cycles
|
2 units on a scale
Interval 0.0 to 4.0
|
0.4 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 0.0
|
1.67 units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksCompare the maximum neuropathic pain score between pregabalin and placebo within cycle 1 and across the 2 cycles. The "ID Pain" scale (also know as the "Identify Pain" scale) is a 6-item, participant-completed screening tool designed to help differentiate nociceptive and neuropathic pain. This pain score also helps to evaluate the presence/absence of neuropathic pain at a given point of time. 1. Did the pain feel like pins and needles? 2. Did the pain feel hot/burning? 3. Did the pain feel numb? 4. Did the pain feel like electrical shocks? 5. Is the pain made worse with the touch of clothing or bed sheets? 6. Is the pain limited to your joints? A "yes" response to questions 1-5 are scored as 1; for question 6, a "yes" is scored as -1. As such, higher scores (approaching 5) signify worse outcomes. The scale's total range for a patient is -1 to 5.
Outcome measures
| Measure |
Second Intervention = Placebo
n=4 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
n=3 Participants
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Maximum Neuropathic Pain Score Between Pregabalin and Placebo Across the 2 Cycles
|
0.5 units on a scale
Interval 0.0 to 2.0
|
0.2 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0.33 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksCTCAE The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
Second Intervention = Placebo
n=3 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Pregabalin
n=5 Participants
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
Number of Subjects That Experienced a Grade 2 or Higher Adverse Events When Taking Pregabalin
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
First Intervention = Pregabalin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Second Intervention = Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
First Intervention = Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Second Intervention = Pregabalin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
First Intervention = Pregabalin
n=5 participants at risk
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
Second Intervention = Placebo
n=4 participants at risk
Pregabalin in cycle 1; placebo in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
|
First Intervention = Placebo
n=3 participants at risk
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
Second Intervention = Pregabalin
n=3 participants at risk
Placebo in cycle 1; pregabalin in cycle 2.
Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities \>Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.
Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
50.0%
2/4 • Number of events 2 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
100.0%
3/3 • Number of events 3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
100.0%
3/3 • Number of events 3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
25.0%
1/4 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
66.7%
2/3 • Number of events 2 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Nervous system disorders
Dizziness
|
80.0%
4/5 • Number of events 4 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/4 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
33.3%
1/3 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
33.3%
1/3 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Gastrointestinal disorders
Stomach pain
|
40.0%
2/5 • Number of events 2 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/4 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/4 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
33.3%
1/3 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Nervous system disorders
Drowsiness/Somnolence
|
20.0%
1/5 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/4 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/4 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
33.3%
1/3 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
25.0%
1/4 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
33.3%
1/3 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
25.0%
1/4 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Reproductive system and breast disorders
Pelvic pain
|
20.0%
1/5 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
50.0%
2/4 • Number of events 2 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
25.0%
1/4 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
33.3%
1/3 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
25.0%
1/4 • Number of events 1 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
0.00%
0/3 • During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
|
Additional Information
Dr. Benyam Muluneh
University of North Carolina Medical Center
Phone: 919-966-3213
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place