Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2021

Detailed Description

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

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

Arms, Groups and Cohorts

  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Episodes of vomiting
    • Time Frame: 5 days after chemotherapeutic administration
  • Severity of nausea
    • Time Frame: 5 days after chemotherapeutic administration
  • Use of rescue drug
    • Time Frame: 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)
    • Time Frame: 5 days after chemotherapeutic administration

Participating in This Clinical Trial

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 Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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