Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis
Phase 3
Completed
- Conditions
- Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
- Interventions
- Registration Number
- NCT04232423
- Lead Sponsor
- Rajavithi Hospital
- Brief Summary
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
A double-blind, placebo-controlled, randomized crossover trial
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description OLN 10-0-5 Olanzapine 5 Mg ORAL TABLET Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3 OLN 0-5-10 Olanzapine 5 Mg ORAL TABLET Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3 OLN 10-0-5 Placebo ORAL TABLET Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3 OLN 5-10-0 Olanzapine 10 Mg ORAL TABLET Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3 OLN 5-10-0 Olanzapine 5 Mg ORAL TABLET Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3 OLN 0-5-10 Olanzapine 10 Mg ORAL TABLET Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3 OLN 0-5-10 Placebo ORAL TABLET Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3 OLN 5-10-0 Placebo ORAL TABLET Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3 OLN 10-0-5 Olanzapine 10 Mg ORAL TABLET Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
- Primary Outcome Measures
Name Time Method Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis 5 days after chemotherapeutic administration No breakthrough vomiting and no using rescue therapy
- Secondary Outcome Measures
Name Time Method Episodes of vomiting 5 days after chemotherapeutic administration Use of rescue drug 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) 5 days after chemotherapeutic administration Severity of nausea 5 days after chemotherapeutic administration
Trial Locations
- Locations (1)
Rajavithi hospital
🇹ðŸ‡Bangkok, Thailand