Comparing olanzapine to placebo for preventing nausea from chemotherapy
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
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bangkok, Bangkok) |
| Trial ID | NCT06850454 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bangkok, Bangkok
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.