Trial Outcomes & Findings for Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients (NCT NCT03137121)
NCT ID: NCT03137121
Last Updated: 2021-08-17
Results Overview
Daily nausea scores (the primary objective) on day 1 to 7 of treatment for each patient from the Olanzapine and Placebo group will be measured using the Visual Analogue Scale rankings from 0-10 where 0 is no nausea and 10 is the maximum nausea experienced by a patient. A Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that can't be directly measured. Patients will be asked to record the average nausea score for each day in a diary and a study nurse will call the patient at the same time each day to remind the patient to record the nausea score and to inquire about any toxicities. The difference in the nausea scores for the patients in each group (Olanzapine and Placebo) will be compared.
COMPLETED
PHASE2/PHASE3
30 participants
Nausea score from the Visual Analogue Scale will be recorded each day daily for 7 days. An average value calculated will be reported for the 7 day period.
2021-08-17
Participant Flow
Participant milestones
| Measure |
Olanzapine
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine: Olanzapine is used as an anti-emetic.
|
Placebo
Patients will receive a placebo orally for 1 to 7 days daily.
Placebo: The placebo is a non-anti-emetic.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Olanzapine
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine: Olanzapine is used as an anti-emetic.
|
Placebo
Patients will receive a placebo orally for 1 to 7 days daily.
Placebo: The placebo is a non-anti-emetic.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
Baseline characteristics by cohort
| Measure |
Olanzapine
n=15 Participants
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine: Olanzapine is used as an anti-emetic.
|
Placebo
n=15 Participants
Patients will receive a placebo orally for 1 to 7 days daily.
Placebo: The placebo is a non-anti-emetic.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9 • n=39 Participants
|
60 years
STANDARD_DEVIATION 11 • n=41 Participants
|
62 years
STANDARD_DEVIATION 7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=39 Participants
|
15 participants
n=41 Participants
|
30 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Nausea score from the Visual Analogue Scale will be recorded each day daily for 7 days. An average value calculated will be reported for the 7 day period.Population: One patient withdrew on their own from the Placebo Group
Daily nausea scores (the primary objective) on day 1 to 7 of treatment for each patient from the Olanzapine and Placebo group will be measured using the Visual Analogue Scale rankings from 0-10 where 0 is no nausea and 10 is the maximum nausea experienced by a patient. A Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that can't be directly measured. Patients will be asked to record the average nausea score for each day in a diary and a study nurse will call the patient at the same time each day to remind the patient to record the nausea score and to inquire about any toxicities. The difference in the nausea scores for the patients in each group (Olanzapine and Placebo) will be compared.
Outcome measures
| Measure |
Olanzapine
n=15 Participants
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine: Olanzapine is used as an anti-emetic.
|
Placebo
n=14 Participants
Patients will receive a placebo orally for 1 to 7 days daily.
Placebo: The placebo is a non-anti-emetic.
|
|---|---|---|
|
Mean Nausea Scores
|
1 units on a scale
Standard Deviation 1
|
9 units on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Number of emetic episodes for each patient on each day of the seven day treatment.Population: One patient withdrew from the Placebo Group.
The number of emetic episodes (a secondary outcome) by each patient in each group, Olanzapine \& Placebo, on each day of treatment will be recorded by each patient on each day of treatment in a diary. A study nurse will contact each patient at the same time of each day of the study to ask the patient to record the number of emetic episodes and report any toxicities.The number of emetic episodes for the patients in each Group for each day of the treatment will be compared.
Outcome measures
| Measure |
Olanzapine
n=15 Participants
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine: Olanzapine is used as an anti-emetic.
|
Placebo
n=14 Participants
Patients will receive a placebo orally for 1 to 7 days daily.
Placebo: The placebo is a non-anti-emetic.
|
|---|---|---|
|
Number of Emetic Episodes
day 1
|
3 episodes
|
3 episodes
|
|
Number of Emetic Episodes
day 2
|
0 episodes
|
3 episodes
|
|
Number of Emetic Episodes
day 3
|
0 episodes
|
3 episodes
|
|
Number of Emetic Episodes
day 4
|
0 episodes
|
3 episodes
|
|
Number of Emetic Episodes
day 5
|
0 episodes
|
3 episodes
|
|
Number of Emetic Episodes
day 6
|
0 episodes
|
3 episodes
|
|
Number of Emetic Episodes
day 7
|
0 episodes
|
3 episodes
|
SECONDARY outcome
Timeframe: Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups.Population: One patient withdrew from Placebo Group.
Adverse events will be measured by patient-reported outcomes questionnaires and the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A study nurse will contact each patient each day of the seven days of treatment to inquire about any toxicities, specifically sedation and appetite. Sedation and appetite will be reported by the patient in each Group on a Visual Analogue Scale of 0 to 10 with 0 being no sedation or no appetite to 10 indicating maximum sedation or maximum appetite.
Outcome measures
| Measure |
Olanzapine
n=15 Participants
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine: Olanzapine is used as an anti-emetic.
|
Placebo
n=14 Participants
Patients will receive a placebo orally for 1 to 7 days daily.
Placebo: The placebo is a non-anti-emetic.
|
|---|---|---|
|
Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".
|
3 Events
|
21 Events
|
Adverse Events
Olanzapine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olanzapine
n=15 participants at risk
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine: Olanzapine is used as an anti-emetic.
|
Placebo
n=14 participants at risk
Patients will receive a placebo orally for 1 to 7 days daily.
Placebo: The placebo is a non-anti-emetic.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Number of events 3 • from baseline through 8 days
One patient withdrew from Placebo Group.
|
42.9%
6/14 • Number of events 21 • from baseline through 8 days
One patient withdrew from Placebo Group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place