Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis Clinical Trial

— OLN-EME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232423
• Other study ID #: 162/2562
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2021
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
• Nausea
• Vomiting

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis	No breakthrough vomiting and no using rescue therapy	5 days after chemotherapeutic administration
Secondary	Episodes of vomiting		5 days after chemotherapeutic administration
Secondary	Severity of nausea		5 days after chemotherapeutic administration
Secondary	Use of rescue drug	using of rescue anti-emetic medication	5 days after chemotherapeutic administration
Secondary	Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)		5 days after chemotherapeutic administration