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

Not Applicable

Recruiting

• Conditions: Medical Oncology; Integrative Oncology; Medical Nutrition Therapy
• Interventions: Other: Diet

• Registration Number: NCT05356182
• Lead Sponsor: State University of New York at Buffalo

Brief 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.

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 Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-02
• Study Start: 2022-05-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Diet Arm	Diet	control diet arm (\~20% protein content)
Low-Protein Diet Arm	Diet	intervention low-protein diet arm (10% protein content)

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.	4 Months	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.

Secondary Outcome Measures

Name	Time	Method
To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention	4 Months	Enrollment rate
To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention	4 Months	Compliance with diet measured by self-report of patient
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies	4 Months	Includes characterization of antigen response by cytokine and chemokine production
To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention	4 Months	Drop-out rate
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	4 Months	Overall Survival(OS)

Trial Locations

Locations (1)

University at Buffalo / Great Lakes Cancer Care; 🇺🇸 Buffalo, New York, United States