OLN-EME: Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

Sponsor

Rajavithi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04232423

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis	Drug: Olanzapine 10 Mg ORAL TABLET Drug: Olanzapine 5 Mg ORAL TABLET Drug: Placebo ORAL TABLET	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

A Double-Blind, Placebo-Controlled, Randomized Crossover TrialA Double-Blind, Placebo-Controlled, Randomized Crossover Trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

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

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

Drug: Olanzapine 5 Mg ORAL TABLET

Drug: Placebo ORAL TABLET

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

Drug: Olanzapine 5 Mg ORAL TABLET

Drug: Placebo ORAL TABLET

Outcome Measures

Primary Outcome Measures

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

Episodes of vomiting [5 days after chemotherapeutic administration]
Severity of nausea [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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