RecruitingNot ApplicableNCT05356182

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

Sponsor

State University of New York at Buffalo

Enrollment

30 participants

Start Date

May 4, 2022

Study Type

INTERVENTIONAL

Conditions

Medical Oncology Integrative Oncology Medical Nutrition Therapy

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

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

Exclusion Criteria8

• 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

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