Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

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

Sponsors

Lead Sponsor: Rajavithi Hospital

Source Rajavithi Hospital
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

Detailed Description

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

Overall Status Not yet recruiting
Start Date March 1, 2020
Completion Date March 31, 2021
Primary Completion Date December 31, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis 5 days after chemotherapeutic administration
Secondary Outcome
Measure Time Frame
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
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE) 5 days after chemotherapeutic administration
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Olanzapine 10 Mg ORAL TABLET

Description: 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

Intervention Type: Drug

Intervention Name: Olanzapine 5 Mg ORAL TABLET

Description: 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

Intervention Type: Drug

Intervention Name: Placebo ORAL TABLET

Description: 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

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

January 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rajavithi Hospital

Investigator Full Name: Charuwan Manmee

Investigator Title: Division of Research and Technology Assessment

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: OLN 0-5-10

Type: Experimental

Description: Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3

Label: OLN 5-10-0

Type: Experimental

Description: Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3

Label: OLN 10-0-5

Type: Experimental

Description: Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3

Acronym OLN-EME
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: A Double-Blind, Placebo-Controlled, Randomized Crossover Trial

Primary Purpose: Treatment

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

Source: ClinicalTrials.gov