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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Medical Oncology, Integrative Oncology, Medical Nutrition Therapy

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Diet Arm<br>control diet arm ( 20% protein content) | Other: Diet<br>* Control diet consisting of 20% protein, intervention diet consisting of 10% protein<br>|
| Active Comparator: Low-Protein Diet Arm<br>intervention low-protein diet arm (10% protein content) | Other: Diet<br>* Control diet consisting of 20% protein, intervention diet consisting of 10% protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 4 Months | 
| To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention | Enrollment rate | 4 Months | 
| To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention | Drop-out rate | 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 | 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) | 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) | 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) | 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Nutrition, Immunotherapy