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

NCT05356182 | Recruiting

• 1 other identifier: STUDY00005755
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Oncology; Integrative Oncology; Medical Nutrition Therapy

Keywords

Oncology; Nutrition; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

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

  4 Months

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

  4 Months

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

  4 Months

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

  4 Months

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

  4 Months

Study Arms (2)

Control Diet Arm

ACTIVE COMPARATOR

control diet arm (\~20% protein content)

Other: Diet

Low-Protein Diet Arm

ACTIVE COMPARATOR

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

Other: Diet

Interventions

Diet OTHER

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

Control Diet Arm; Low-Protein Diet Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Cancer Research and Integrative Oncology

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 2, 2022
• Study Start: May 4, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-05

Locations

US (1)