Comparing Weekly and Every 3 Weeks Ondansetron to Prevent Nausea and Vomiting in Chemotherapy with PD-1 Blockade

What this Trial Is About

Researchers are evaluating how often ondansetron should be given to prevent nausea and vomiting caused by chemotherapy combined with PD-1 blockade treatment in patients with malignant solid tumors. This randomized study compares the safety and effectiveness of giving ondansetron weekly versus every three weeks. The study addresses the common and distressing side effects of nausea and vomiting, which can affect quality of life and treatment adherence, especially since PD-1 blockade can cause gastrointestinal immune-related side effects including nausea. Participants will receive either ondansetron every three weeks or weekly, combined with aprepitant and dexamethasone, as part of their chemotherapy and PD-1 blockade regimen. Ondansetron is taken orally at 24 mg per day for three days either weekly or every three weeks. Aprepitant is given orally at 125 mg for one day every three weeks, and dexamethasone is administered intravenously at 10 mg for one day every three weeks. The study aims to determine which schedule better prevents nausea and vomiting during chemotherapy. During the study, researchers will monitor participants for up to six weeks, focusing on the complete response rate regarding nausea and vomiting prevention. They will track the time until the first vomiting episode and the proportion of patients who remain free from nausea and vomiting each week. Participants will be assessed regularly for side effects and overall treatment response to gather safety and efficacy data. The study is sponsored by Hubei Cancer Hospital and plans to enroll adults aged 18 and older with specific eligibility criteria.

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