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

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT05356182
Status
Recruiting
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Conditions

  • Integrative Oncology
  • Medical Nutrition Therapy
  • Medical Oncology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diet — OTHER
    Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Study Details

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.

Key Dates

Start date
May 4, 2022
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Diet Arm
    control diet arm (\~20% protein content)
  • Active Comparator: Low-Protein Diet Arm
    intervention low-protein diet arm (10% protein content)

Primary Outcome Measure

To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. [ Time Frame: 4 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University at Buffalo / Great Lakes Cancer CareBuffaloNew York14203
Ashlee Lang, MPH
[email protected]
716-860-0267
Kyle Pasquariello, MA
[email protected]
716-529-6470
Roberto Pili, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University at Buffalo / Great Lakes Cancer Care· Buffalo, NY

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