Trial · NCT03137121
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
NCT03137121, Phase 2, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2021-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients. Trials, record NCT03137121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03137121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
- NCT number
- NCT03137121
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Advanced Cancer
- Interventions
- Olanzapine, Placebo
- First posted
- 2017-05-02
- Last updated
- 2021-08-17
- Results first posted
- 2021-08-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Nausea Scores | 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. | 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. |
| Secondary | Number of Emetic Episodes | Number of emetic episodes for each patient on each day of the seven day treatment. | 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. |
| Secondary | Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0". | Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups. | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Nausea Scores | 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. | One patient withdrew on their own from the Placebo Group | units on a scale | MEAN |
| SECONDARY | Number of Emetic Episodes | Number of emetic episodes for each patient on each day of the seven day treatment. | One patient withdrew from the Placebo Group. | episodes | NUMBER |
| SECONDARY | Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0. | Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups. | One patient withdrew from Placebo Group. | Events | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Nausea Scores | Olanzapine | 1 | Standard Deviation 1 | units on a scale | |
| Mean Nausea Scores | Placebo | 9 | Standard Deviation 2 | units on a scale | |
| Number of Emetic Episodes | Olanzapine | day 1 | 3 | episodes | |
| Number of Emetic Episodes | Placebo | day 1 | 3 | episodes | |
| Number of Emetic Episodes | Olanzapine | day 2 | 0 | episodes | |
| Number of Emetic Episodes | Placebo | day 2 | 3 | episodes | |
| Number of Emetic Episodes | Olanzapine | day 3 | 0 | episodes | |
| Number of Emetic Episodes | Placebo | day 3 | 3 | episodes | |
| Number of Emetic Episodes | Olanzapine | day 4 | 0 | episodes | |
| Number of Emetic Episodes | Placebo | day 4 | 3 | episodes |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olanzapine | 15 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Olanzapine | 15 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Olanzapine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Olanzapine | 3 | 15 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 14 | 21 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olanzapine | 0 | 15 |
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, other adverse events | Olanzapine | 3 | 15 |
| Total, other adverse events | Placebo | 6 | 14 |
| Total, serious adverse events | Olanzapine | 0 | 15 |
| Total, serious adverse events | Placebo | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32379269 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Olanzapine vs Placebo: deaths from any cause | Trial comparisons |
| Olanzapine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03137121
GET https://conductscience.org/api/trials/v1/NCT03137121/registered