NCT05356182

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Diet	Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Timeline

• Start date: 2022-05-04
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2022-05-02
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States