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

NCT ID: NCT05356182

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2027-02-28

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).

Conditions

Medical Oncology; Integrative Oncology; Medical Nutrition Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Diet Arm

control diet arm (\~20% protein content)

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Low-Protein Diet Arm

intervention low-protein diet arm (10% protein content)

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Interventions

Diet

Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Roberto Pili

Associate Dean for Cancer Research and Integrative Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Ashlee Lang, MPH

Role: primary

alang@kaleidahealth.org

716-860-0267

Kyle Pasquariello, MA

Role: backup

kpasquariello@gppconline.com

716-529-6470

Other Identifiers

STUDY00005755

Identifier Type: -

Identifier Source: org_study_id