Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Comparing olanzapine to placebo for preventing nausea from chemotherapy

Official title: A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy

Run by Mahidol University · NCT06850454 · Data updated 2026-11-12

This study tests if the medication olanzapine can help prevent nausea and vomiting in people getting chemotherapy for the first time.

More Chemotherapy-induced Nausea and Vomiting trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment140 (estimated)
SponsorMahidol University
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Bangkok, Bangkok)
StatusRecruiting
StartedJanuary 10, 2025
Main results expectedJanuary 10, 2026
Study endsJanuary 31, 2026
Registry record updatedFebruary 27, 2025
Trial IDNCT06850454 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old with histologically confirmed cancer starting their first dose of oxaliplatin, irinotecan, or carboplatin.

Probably not a fit

Patients who are pregnant, breastfeeding, or have certain medical conditions such as uncontrolled brain metastasis or severe kidney impairment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of olanzapine compared to a placebo in preventing nausea and vomiting in patients undergoing moderately emetogenic chemotherapy. It is a randomized, phase 3 trial that includes patients receiving their first dose of chemotherapy agents such as oxaliplatin, irinotecan, or carboplatin. Participants will receive either olanzapine or a placebo in addition to standard antiemetic treatments to assess the difference in outcomes related to nausea and vomiting.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option to reduce chemotherapy-induced nausea and vomiting, improving the quality of life for patients undergoing cancer treatment.

How similar studies have gone: Previous studies have shown promising results with olanzapine in managing chemotherapy-induced nausea and vomiting, indicating that this approach has potential based on existing evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
* age of \>18 years old

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

Where it's running

  • Faculty of Medicine Siriraj Hospital, Mahidol University
    Bangkok, Bangkok, Thailand
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.