Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

Phase 3

Completed

• Conditions: Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
• Interventions: Drug: Olanzapine 10 Mg ORAL TABLET; Drug: Olanzapine 5 Mg ORAL TABLET; Drug: Placebo ORAL TABLET

• 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

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2020-03-01
• Primary Completion: 2021-06-30
• Status Verified: 2021-07
• Study Completion: 2021-09-30
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21

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; 🇹🇭 Bangkok, Thailand