Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

Study Overview
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Brief Summary
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To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo

Detailed Description
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A double-blind, placebo-controlled, randomized crossover trial

Official Title
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Efficacy and Dosage of Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis in Women With Gynecologic Cancers Receiving Carboplatin-based Regimen : a Double-blind, Placebo-controlled, Randomized Crossover Trial

Conditions
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Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis

Intervention / Treatment
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* Drug: Olanzapine 10 Mg ORAL TABLET
* Drug: Olanzapine 5 Mg ORAL TABLET
* Drug: Placebo ORAL TABLET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with gynecological cancer receiving carboplatin-based chemotherapeutic regimen ECOG performance status 0-1 Normal bone marrow, liver, and renal functions Can speak and write in Thai language Exclusion Criteria: Women with nausea or vomiting prior to chemotherapeutic administration Pregnant women Women with active infection Women with bowel obstruction Women with symptomatic brain metastases Women who received dopamine receptor antagonists within 1 week before chemotherapeutic administration Women who received corticosteroid within 1 week before chemotherapeutic administration Women with past history of chemotherapy or radiotherapy Women with psychiatric disorders Women with poor controlled diabetes mellitus Women who received anticonvulsant medication Women with history of neuroleptic malignant syndrome Women with history of olanzapine allergy Women with history of lactose intolerance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A Double-Blind, Placebo-Controlled, Randomized Crossover Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OLN 0-5-10<br>Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3 | Drug: Olanzapine 10 Mg ORAL TABLET<br>* Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>Drug: Olanzapine 5 Mg ORAL TABLET<br>* Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>Drug: Placebo ORAL TABLET<br>* Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>|
| Experimental: OLN 5-10-0<br>Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3 | Drug: Olanzapine 10 Mg ORAL TABLET<br>* Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>Drug: Olanzapine 5 Mg ORAL TABLET<br>* Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>Drug: Placebo ORAL TABLET<br>* Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>|
| Experimental: OLN 10-0-5<br>Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3 | Drug: Olanzapine 10 Mg ORAL TABLET<br>* Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>Drug: Olanzapine 5 Mg ORAL TABLET<br>* Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>Drug: Placebo ORAL TABLET<br>* Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis | No breakthrough vomiting and no using rescue therapy | 5 days after chemotherapeutic administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of vomiting |  | 5 days after chemotherapeutic administration | 
| Severity of nausea |  | 5 days after chemotherapeutic administration | 
| Use of rescue drug | using of rescue anti-emetic medication | 5 days after chemotherapeutic administration | 
| Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE) |  | 5 days after chemotherapeutic administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olanzapine, Chemotherapy-induced nausea and vomiting, Carboplatin, Gynecologic cancer