Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy

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

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy Induced Nausea and Vomiting
• Intervention / Treatment: Drug: olanzapine; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Suthinee Ithimakin Ithimakin, MD; Phone Number: 66898127440; Email: aesi105@yahoo.co.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Faculty of Medicine Siriraj Hospital, Mahidol University
    • Contact: Suthinee Ithimakin, MD; Phone Number: 66898127440; Email: aesi105@yahoo.co.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: olanzapine; olanzapine 5 mg on day 1-4	Drug: olanzapine; olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Placebo Comparator: placebo; placebo 5 mg day 1-4	Drug: Placebo; placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total protection rate of nausea and vomiting	Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm	5 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mahidol University

Publications and helpful links

General Publications

• Shen J, Zhao J, Jin G, Li H, Jiang Y, Wu Y, Gao J, Chen F, Li J, Wang W, Li Q. A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy. J Cancer Res Clin Oncol. 2024 May 28;150(5):283. doi: 10.1007/s00432-024-05712-7.
• Yamamoto S, Iihara H, Uozumi R, Kawazoe H, Tanaka K, Fujita Y, Abe M, Imai H, Karayama M, Hayasaki Y, Hirose C, Suda T, Nakamura K, Suzuki A, Ohno Y, Morishige KI, Inui N. Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials. BMC Cancer. 2021 Jul 19;21(1):832. doi: 10.1186/s12885-021-08572-3.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): January 10, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: oxaliplatin; carboplatin; olanzapine; irinotecan; moderately emetogenic chemotherapy
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Central Nervous System Depressants; Neurotransmitter Agents; Membrane Transport Modulators; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Antipsychotic Agents; Olanzapine
• Other Study ID Numbers: 811/2567(IRB3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared upon request
• IPD Sharing Time Frame: After study completion and published, lasting for 5 years
• IPD Sharing Access Criteria: The IPD will be provided upon request by email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes