Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

Last updated: February 21, 2025
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

3

Condition

Vomiting

Treatment

Placebo

olanzapine

Clinical Study ID

NCT06850454
811/2567(IRB3)
  • Ages > 18
  • All Genders

Study Summary

A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • histologically confirmed cancer patients who will be started on first dose ofoxaliplatin, irinotecan or carboplatin

  • age of >18 years old

Exclusion

Exclusion Criteria:

  • pregnancy or breast feeding

  • has emetic episode within 24 hours

  • gut obstruction

  • uncontrolled brain metastasis

  • allergy to or current use of olanzapine

  • concomittant moderate or high emetogenic chemotherapy on day 2-5

  • Total bilirubin > 2 mg/dl or creatinine clearance < 30 ml/min

  • unable to swallow drug

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 10, 2025
Estimated Completion Date:
January 31, 2026

Study Description

A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy

Connect with a study center

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

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