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Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

NCT04232423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-01-21

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Department of Medical Services Ministry of Public Health of Thailand

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04232423 on ClinicalTrials.gov