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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bangkok, Bangkok) |
| Status | Recruiting |
| Started | January 10, 2025 |
| Main results expected | January 10, 2026 |
| Study ends | January 31, 2026 |
| Registry record updated | February 27, 2025 |
| Trial ID | NCT06850454 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
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand Recruiting
Study contacts
- Study coordinator: Suthinee Ithimakin Ithimakin, MD
- Email: aesi105@yahoo.co.th
- Phone: 66898127440
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Fosaprepitant plus palonosetron with dexamethasone (± olanzapine) to prevent nausea from multi-day highly emetogenic chemotherapy
This trial tests whether giving fosaprepitant and palonosetron with dexamethasone, with or without olanzapine, can prevent nausea and vomiting in adults starting multi-day highly emetogenic chemotherapy.
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This study is testing if dolasetron can help prevent nausea and vomiting in children with leukemia who are receiving chemotherapy.
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Using Thalidomide to Reduce Nausea from Chemotherapy in Pancreatic Cancer
This study is testing if thalidomide can help reduce nausea and improve the quality of life for people with pancreatic cancer who are receiving chemotherapy.
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Using digital technology to manage chemotherapy-related nausea and vomiting in older adults
This study is testing a digital program to help older adults manage nausea and vomiting while they go through chemotherapy to see if it improves their quality of life.
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HR20013 for preventing nausea and vomiting in cancer patients receiving chemotherapy
This real-world study tests whether HR20013 helps prevent nausea and vomiting in adults with cancer who are getting chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.