Trial Outcomes & Findings for Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases (NCT NCT01767935)
NCT ID: NCT01767935
Last Updated: 2018-11-14
Results Overview
Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
24 hours
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
Treatment (Cryosurgery and Radiation Therapy)
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
Baseline characteristics by cohort
| Measure |
Treatment (Cryosurgery and Radiation Therapy)
n=1 Participants
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNumerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.
Outcome measures
| Measure |
Treatment (Cryosurgery and Radiation Therapy)
n=1 Participants
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
|
5 score on a scale
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.
Outcome measures
| Measure |
Treatment (Cryosurgery and Radiation Therapy)
n=1 Participants
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
|
2 mg
|
SECONDARY outcome
Timeframe: Up to 24 weeksOutcome measures
| Measure |
Treatment (Cryosurgery and Radiation Therapy)
n=1 Participants
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
0 events
|
SECONDARY outcome
Timeframe: Up to 24 weeksQuestions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome
Outcome measures
| Measure |
Treatment (Cryosurgery and Radiation Therapy)
n=1 Participants
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Pain After Cryosurgery, as Measured by the BPI
Least pain
|
7 score on a scale
|
|
Pain After Cryosurgery, as Measured by the BPI
Average Pain
|
10 score on a scale
|
|
Pain After Cryosurgery, as Measured by the BPI
Right now
|
2 score on a scale
|
SECONDARY outcome
Timeframe: Up to 24 weeks post-cryosurgeryCount of participants that survived.
Outcome measures
| Measure |
Treatment (Cryosurgery and Radiation Therapy)
n=1 Participants
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Number of Participants Who Survived
|
1 Participants
|
Adverse Events
Treatment (Cryosurgery and Radiation Therapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Childs
Wake Forest University Health Sciences
Phone: 336-716-2471
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place