Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

Phase 3

Recruiting

• Conditions: Chemotherapy Induced Nausea and Vomiting
• Interventions: Drug: olanzapine; Drug: Placebo

• Registration Number: NCT06850454
• Lead Sponsor: Mahidol University

Brief Summary

A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy

Detailed Description

A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study Start: 2025-01-10
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-01-10
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
• age of >18 years old

Exclusion Criteria

• pregnancy or breast feeding
• has emetic episode within 24 hours
• gut obstruction
• uncontrolled brain metastasis
• allergy to or current use of olanzapine
• concomittant moderate or high emetogenic chemotherapy on day 2-5
• Total bilirubin > 2 mg/dl or creatinine clearance < 30 ml/min
• unable to swallow drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
olanzapine	olanzapine	olanzapine 5 mg on day 1-4
placebo	Placebo	placebo 5 mg day 1-4

Primary Outcome Measures

Name	Time	Method
total protection rate of nausea and vomiting	5 days	Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm

Secondary Outcome Measures

Name	Time	Method
no nausea rate	5 days
severity of nausea and vomiting	5 days	Number of patients with grade of nausea or vomiting according to CT-CAE
adverse events	5 days	Number of patients with other adverse event(s)
rescue therapy	5 days	Number of patients requiring additional therapy
quality of life score	5 days	EQ-5D-5L score
Cost	5 days	medical cost excluding chemotherapy and prophylactic measures

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand