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

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: hg7913@hotmail.com
• Phone: 13886048178

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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.