Actively Recruiting
Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade: a Randomized Clinical Trial
Led by Hubei Cancer Hospital · Updated on 2024-02-29
98
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Pathologically or cytologically confirmed malignant solid tumors
- Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade
- PD-1 tumor proportion score (TPS) greater than 1%
- Adequate blood counts: leucocyte count at least 4000/μL, hemoglobin at least 9.00 g/dL, platelet count at least 100 x 10^3/μL
- Liver function with alanine aminotransferase and aspartate aminotransferase no more than 2.0 times the upper limit of normal
- Kidney function with creatinine clearance at least 60 mL/min/1.73 m2
- Estimated survival time longer than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Able to provide informed consent and sign written consent form
You will not qualify if you...
- Nausea or vomiting caused by reasons other than chemotherapy and PD-1 blockade
- History of other malignant tumors
- Unable to read, understand, or complete questionnaires
- Allergy to any study drugs
- Use of other antiemetic drugs within 24 hours before the first study medication dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks
Participants receive ondansetron combined with aprepitant and dexamethasone to prevent nausea and vomiting induced by chemotherapy combined with PD-1 blockade.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
Research Team
G
Guang Han, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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