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

Inclusion Criteria: * 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 Criteria: * • 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…