A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies

Recruiting now · Not applicable

Conditions studied: Medical Oncology, Integrative Oncology, Medical Nutrition Therapy

In brief

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.

Key facts

Study ID

NCT05356182

Run by

State University of New York at Buffalo

People needed

30

Starts

2022-05-04

Expected to finish

2028-02-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.
• Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
• Life expectancy of at least 6 months
• Adults ≥ 18 years of age
• Adequate hematologic, renal, and liver function as evidenced by the following:
• White blood cell (WBC) ≥ 2,500 cells/μL
• Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
• Platelet Count ≥ 100,000 cells/μL
• Hemoglobin (HgB) ≥ 9.0 g/dL
• Creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 2 x upper limit of normal (ULN)
• Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
• Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN

You may not qualify if…

• • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
• Treatment with any of the following medications or interventions within 28 days of registration:
• Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
• High dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week)
• A requirement for systemic immunosuppressive therapy for any reason
• Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 1 week prior to registration
• A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
• Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives

Where it is running

• University at Buffalo / Great Lakes Cancer Care — Buffalo, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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