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

State University of New York at Buffalo30 enrolled

Overview

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.

This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Medical Oncology Integrative Oncology Medical Nutrition Therapy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.

Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.

Time frame: 4 Months

To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.

Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.

Time frame: 4 Months

Secondary Outcomes

To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies

Includes isolation and characterization of antigen specific T cell clones

Time frame: 4 Months

To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies

Includes evaluation of antigen specific T cell populations by spectratyping T cell receptor expression

Time frame: 4 Months

To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies

Includes characterization of antigen response by cytokine and chemokine production

Time frame: 4 Months

To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention

Enrollment rate

Time frame: 4 Months

To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention

Drop-out rate

Time frame: 4 Months

To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention

Compliance with diet measured by self-report of patient

Time frame: 4 Months

To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria

Objective Response Rate (ORR)

Time frame: 4 Months

To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria

Progression-Free Survival (PFS)

Time frame: 4 Months

To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria

Overall Survival(OS)

Time frame: 4 Months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes