Comparing Olanzapine and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting
The Efficacy of Steroid-Sparing Anti-Emetic Therapy in Patients Treated With High or Moderate Emetogenic Chemotherapy; Single Center Non-Inferiority Open Label Randomized Controlled Trial
This study tests whether olanzapine can help prevent nausea and vomiting better than dexamethasone in patients getting chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Guthrie Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Sayre, Pennsylvania) |
| Trial ID | NCT05590923 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of olanzapine versus dexamethasone in preventing nausea and vomiting in patients undergoing chemotherapy. Participants will be randomly assigned to receive either olanzapine or dexamethasone during their first cycle of chemotherapy, with a crossover to the other treatment in the second cycle. The study focuses on patients receiving high or moderate emetogenic chemotherapy, and aims to determine if olanzapine can serve as a steroid-sparing alternative. The duration of participation will last for two cycles of chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed cancer diagnosis starting their first cycle of high or moderate emetogenic chemotherapy.
Not a fit: Patients who have experienced nausea or vomiting within 24 hours prior to chemotherapy or those currently on glucocorticoid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and potentially safer option for managing chemotherapy-induced nausea and vomiting.
How similar studies have performed: Other studies have shown promising results with olanzapine for nausea and vomiting, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older * confirmed cancer diagnosis * starting cycle 1 of an FDA approved treatment that is categorized as high-emetogenic (nausea and vomiting inducing) chemotherapy per National Comprehensive Cancer Network® guidelines * Eastern Cooperative Oncology Group performance score of 0 or 1 * appropriate renal function * appropriate hepatic function * appropriate hematologic function. Exclusion Criteria: * Patients will be excluded if they experience nausea or vomiting up to 24 hours before chemotherapy, * currently on a glucocorticoid therapy * contraindication to glucocorticoid therapy * taking any medication that has antiemetic properties. * scheduled or planned to receive radiation within one week of or concurrently with chemotherapy * brain metastases.
Where this trial is running
Sayre, Pennsylvania
- Robert Packer Hospital — Sayre, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Zane Waite, PharmD, BCOP — The Guthrie Clinic
- Study coordinator: Zane Waite, PharmD, BCOP
- Email: zane.waite@guthrie.org
- Phone: 570-887-6072
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.