Actively Recruiting
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
Led by State University of New York at Buffalo · Updated on 2026-04-03
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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 body's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Histologically confirmed solid tumor malignancies suitable for immunotherapy with immune checkpoint inhibitors
- Metastatic disease confirmed by bone scan or CT scan
- Life expectancy of at least 6 months
- Adequate hematologic function: WBC 2,500 cells/bcL, ANC 1,000 cells/bcL, Platelet count 100,000 cells/bcL, Hemoglobin 9.0 g/dL
- Adequate renal and liver function: Creatinine 2.0 mg/dL, Total bilirubin 2 x ULN, AST and ALT 2.5 x ULN
You will not qualify if you...
- ECOG performance status of 2 or higher
- Treatment with systemic corticosteroids within 28 days before registration (inhaled, intranasal, and topical steroids allowed)
- Treatment with high dose calcitriol (> 7.0 bcg/week) within 28 days before registration
- Requirement for systemic immunosuppressive therapy
- Infection requiring parenteral antibiotics or fever above 100.5F (38.1C) within 1 week before registration
- Known allergy or contraindication to contrast dye for CT imaging
- Any medical condition or intervention that could interfere with study adherence or objectives as judged by the Principal Investigator
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.
1 visit (in-person)
Duration - 4 months
Participants receive either a low-protein diet or a control diet while undergoing immunotherapy to assess the feasibility and effects of the dietary intervention.
Regular visits for dietary assessment and immunotherapy monitoring during the 4-month intervention
Trial Site Locations
Total: 1 location
1
University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, United States, 14203
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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