Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03137121|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Olanzapine Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||There will be two groups for the study: Group 1 will receive the study drug and Group 2 will receive a placebo.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Patients will receive the study drug or placebo in a double-blind fashion.|
|Official Title:||Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patient - A Pilot, Dose-Finding Trial|
|Actual Study Start Date :||July 12, 2017|
|Actual Primary Completion Date :||July 12, 2019|
|Estimated Study Completion Date :||July 15, 2020|
Experimental: Group 1
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Olanzapine is used as an anti-emetic.
Other Name: Zyprexa
Placebo Comparator: Group 2
Patients will receive a placebo orally for 1 to 7 days daily.
The placebo is a non-anti-emetic.
- Effect of olanzapine [ Time Frame: Nausea score from the Visula Analogue Scale will be recorded each day daily for 7 days ]Daily nausea scores (the primary objective) on day 1 to 7 of treatment for each patient from Groups 1 and 2 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. 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 (Group 1 and Group 2) will be compared.
- Effect of Olanzapine [ Time Frame: 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 (1 and 2) 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.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". [ Time Frame: Daily assessment for 7 days for each patient in Groups 1 and 2 ]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.
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): NCT03137121
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Wisconsin|
|Hospital Sisters Health System (HSHS) St. Vincent Hospital|
|Green Bay, Wisconsin, United States, 54301|
|Principal Investigator:||Rudolph Navari, MD||University of Alabama at Birmingham|