Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis (OLN-EME)

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

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

Study Overview

• Status: Completed
• Conditions: Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
• Intervention / Treatment: Drug: Olanzapine 10 Mg ORAL TABLET; Drug: Olanzapine 5 Mg ORAL TABLET; Drug: Placebo ORAL TABLET

Detailed Description

A double-blind, placebo-controlled, randomized crossover trial

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis	No breakthrough vomiting and no using rescue therapy	5 days after chemotherapeutic administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of vomiting		5 days after chemotherapeutic administration
Severity of nausea		5 days after chemotherapeutic administration
Use of rescue drug	using of rescue anti-emetic medication	5 days after chemotherapeutic administration
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)		5 days after chemotherapeutic administration

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Carboplatin; Olanzapine; Gynecologic cancer; Chemotherapy-induced nausea and vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: 162/2562

Drug and device information, study documents

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