Actively Recruiting
Phase 3 Study on How Nutrition Affects Immunotherapy Outcomes in Adults with Cancer
Led by Qingdao Central Hospital · Updated on 2024-07-15
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how nutritional status affects the outcomes of immunotherapy in cancer patients. Many cancer patients are malnourished at diagnosis, which can increase treatment complications, risk of stopping care, and reduce survival rates. This Phase III study aims to better understand this relationship and improve patient care during immunotherapy. Participants will be randomly assigned to receive either a combination of megestrol acetate 160 mg and olanzapine 2.5 mg orally every day or a placebo starch powder 50 mg orally every day. The study does not use masking or blinding, allowing participants and researchers to know which treatment is given. Treatment lasts over a period to assess the impact on cancer outcomes alongside nutritional status. During the study, participants will be monitored for overall response rate ORR and progression-free survival PFS over 12 months. Researchers will evaluate tumor lesions using imaging criteria and assess patient performance status and organ function before and during treatment. Participants must be able to swallow oral medications and comply with study procedures. Safety and treatment effects will be closely observed throughout the trial period, which starts in June 2024 and ends in May 2027.
CONDITIONS
Brief Title
Nutrition Impact on Immunotherapy of Cancer
Research Team
K
Keke Nie, MD
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