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Study of a Low-Protein Diet to Boost Immune Therapy Effects in Adults With Cancer
Led by State University of New York at Buffalo · Updated on 2026-04-03
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the effects of a low-protein diet on cancer patients receiving immunotherapy treatments. The study aims to see if reducing protein intake can change the tumor environment and boost the bodys immune response, potentially enhancing the effects of immune checkpoint inhibitors. This is a randomized, open-label study conducted at a single center to explore the feasibility of this dietary approach. Participants will be randomly assigned to one of two groups one receiving immunotherapy plus a control diet containing about 20% protein, and the other receiving immunotherapy combined with a low-protein diet containing 10% protein. The study intervention lasts for 4 months, during which the dietary impact on immune response and treatment effects will be evaluated. Throughout the 4-month study period, participants will be monitored for their ability to follow the dietary plan and for any changes in immune response to immunotherapy. Researchers will assess safety, tolerability, clinical efficacy using RECIST v1.1 criteria, and enrollment and drop-out rates. Laboratory tests and imaging scans will also be conducted to evaluate disease progression and treatment impact.
CONDITIONS
Brief Title
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
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