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
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.
CONDITIONS
Official 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 or older
- Diagnosed with solid tumor cancers suitable for immune checkpoint inhibitor treatments
- Have metastatic disease confirmed by bone scan or CT scans
- Life expectancy of at least 6 months
- Adequate blood counts and organ function with specific laboratory values: WBC ≥ 2,500 cells/µL, ANC ≥ 1,000 cells/µL, Platelets ≥ 100,000 cells/µL, Hemoglobin ≥ 9.0 g/dL, Creatinine ≤ 2.0 mg/dL, Total bilirubin ≤ 2 times upper normal limit, AST and ALT ≤ 2.5 times upper normal limit
You will not qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher
- Use of systemic corticosteroids or high dose calcitriol (>7.0 µg/week) within 28 days before registration
- Need for systemic immunosuppressive therapy
- Any infection requiring IV antibiotics or fever > 100.5°F (38.1°C) within 1 week before registration
- Known allergy or intolerance to contrast dye used in CT scans
- Any medical condition or intervention that may interfere with study participation or compliance
AI-Screening
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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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