Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis
Overview
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
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 30, 2021
Detailed Description
A double-blind, placebo-controlled, randomized crossover trial
Interventions
- Drug: Olanzapine 10 Mg ORAL TABLET
- 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
- Drug: Olanzapine 5 Mg ORAL TABLET
- 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
- Drug: Placebo ORAL TABLET
- 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
Arms, Groups and Cohorts
- Experimental: OLN 0-5-10
- Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
- Experimental: OLN 5-10-0
- Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
- Experimental: OLN 10-0-5
- Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
Clinical Trial Outcome Measures
Primary Measures
- Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
- Time Frame: 5 days after chemotherapeutic administration
- No breakthrough vomiting and no using rescue therapy
Secondary Measures
- Episodes of vomiting
- Time Frame: 5 days after chemotherapeutic administration
- Severity of nausea
- Time Frame: 5 days after chemotherapeutic administration
- Use of rescue drug
- Time Frame: 5 days after chemotherapeutic administration
- using of rescue anti-emetic medication
- Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
- Time Frame: 5 days after chemotherapeutic administration
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Rajavithi Hospital
- Provider of Information About this Clinical Study
- Sponsor
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