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

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.

Study Overview

• Status: Recruiting
• Conditions: Medical Oncology; Integrative Oncology; Medical Nutrition Therapy
• Intervention / Treatment: Other: Diet

Detailed Description

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo / Great Lakes Cancer Care
      • Contact: Ashlee Lang, MPH; Phone Number: 716-860-0267; Email: alang@kaleidahealth.org
      • Contact: Kyle Pasquariello, MA; Phone Number: 716-529-6470; Email: kpasquariello@gppconline.com
      • Principal Investigator: Roberto Pili, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; Nutrition; Oncology
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STUDY00005755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No