Comparing weekly and every 3 weeks ondansetron for preventing chemotherapy-induced nausea and vomiting

Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade：an Randomized Clinical Trial

This study is testing whether giving ondansetron weekly or every three weeks can better help cancer patients avoid nausea and vomiting from chemotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hubei Cancer Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06080880 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of administering ondansetron either weekly or every three weeks to prevent nausea and vomiting in patients undergoing chemotherapy combined with PD-1 blockade. Given that nausea and vomiting are significant side effects of chemotherapy, the study seeks to determine which dosing schedule provides better control of these symptoms. Participants will be randomly assigned to receive one of the two treatment regimens, and their responses will be monitored to assess the outcomes. The findings may lead to improved management strategies for patients experiencing these adverse effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed malignant solid tumors scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade.

Not a fit: Patients whose nausea or vomiting is caused by factors other than chemotherapy and PD-1 blockade may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the quality of life for patients undergoing chemotherapy by providing more effective prevention of nausea and vomiting.

How similar studies have performed: Previous studies have shown success in managing chemotherapy-induced nausea and vomiting, suggesting that this approach may also yield beneficial results.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years, no gender limit;
2. Pathologically or cytologically confirmed malignant solid tumors;
3. Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；
4. TPS \> 1 %(PD-1);
5. Adequate hematological function (leucocyte count ≥ 4000/μL \[to convert to ×109/L,multiply by 0.001\], hemoglobin ≥ 9.00 g/dL \[to convert to grams per liter, multiply by 10\], and platelet count ≥ 100 × 103/μL \[to convert to ×109/L, multiply by 1\]);
6. Hepatic function (alanine aminotransferase and aspartate aminotransferase ≤ 2.0 times the upper limit of the reference ranges), and renal function (creatinine clearance ≥ 60 mL/min/1.73 m2 \[to convert to millimeters per second per meter-squared, multiply by 0.0167\])；
7. Estimated survival time \> 6 months；
8. ECOG 0-1 points；
9. Participants being informed and signed written consents.

Exclusion Criteria:

1. Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;
2. Participants with other malignant tumors history previously;
3. Inability to read, comprehend, and finish questionnaires;
4. Allergic to the drugs included in this study.
5. Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.

Where this trial is running

Wuhan, Hubei

• Hubei Cancer Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Guang Han, MD — Hubei Cancer Hospital, Wuhan, HuBei, China, 430079
• Study coordinator: Guang Han, MD

Conditions: Nausea With Vomiting Chemotherapy-Induced, Chemotherapy-induced nausea and vomiting, PD-1 blockade, Ondanstron