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Completed

NCT Number: NCT04232423

Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

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

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Key information

Conditions

Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Rajavithi hospital

Bangkok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine 10 Mg ORAL TABLET

Drug
  • 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

Drug
  • 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

Drug
  • 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

Primary outcomes

  1. Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis

    Time frame: 5 days after chemotherapeutic administration

    No breakthrough vomiting and no using rescue therapy

Secondary outcomes

  1. Episodes of vomiting

    Time frame: 5 days after chemotherapeutic administration

  2. Severity of nausea

    Time frame: 5 days after chemotherapeutic administration

  3. Use of rescue drug

    Time frame: 5 days after chemotherapeutic administration

    using of rescue anti-emetic medication

  4. Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)

    Time frame: 5 days after chemotherapeutic administration

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study 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

Acronym: OLN-EME

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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