Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05403580|
Recruitment Status : Recruiting
First Posted : June 3, 2022
Last Update Posted : June 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm Hematopoietic and Lymphoid Cell Neoplasm||Drug: Olanzapine Drug: Placebo Administration Other: Questionnaire Administration||Phase 3|
I. To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.
I. To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting.
II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive olanzapine orally (PO) every night on days 1-28.
ARM II: Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial|
|Actual Study Start Date :||June 3, 2022|
|Estimated Primary Completion Date :||February 15, 2023|
|Estimated Study Completion Date :||February 15, 2024|
Experimental: Arm I (olanzapine)
Patients receive olanzapine PO every night on days 1-28.
Other: Questionnaire Administration
Active Comparator: Arm II (placebo, olanzapine)
Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
Drug: Placebo Administration
Other: Questionnaire Administration
- Change in nausea score [ Time Frame: Baseline to 24 hours of treatment ]Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.
- Daily nausea and vomiting scores [ Time Frame: Up to 28 days ]Chronic nausea this is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
- Daily episodes of vomiting/retching (number and time) [ Time Frame: Up to 28 days ]Chronic nausea that is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
- Utilization of rescue therapy [ Time Frame: Up to 28 days ]Baseline evaluation that includes assessment of symptom intensity for appetite, nausea, fatigue, sedation, and pain, all measured and recorded on a numeric rating score. (0 indicated the worst possible; 10, best possible).
- Incidence of adverse events with olanzapine [ Time Frame: Up to 28 days ]Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05403580
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trial Referral Office 855-776-0015 email@example.com|
|Principal Investigator: Charles L. Loprinzi, M.D.|
|Principal Investigator:||Charles L Loprinzi||Mayo Clinic in Rochester|