Recruiting

Dietary Intervention

Sponsor:

State University of New York at Buffalo

Code:

NCT05356182

Conditions

Medical Oncology

Integrative Oncology

Medical Nutrition Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet

Study Details

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

Study ID

NCT05356182

Start date

May 4, 2022

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Diet

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

Primary outcome measure

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

Central Contacts and Locations

Locations

University at Buffalo / Great Lakes Cancer Care

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ashlee Lang, MPH

716-860-0267alang@kaleidahealth.org

Kyle Pasquariello, MA

716-529-6470kpasquariello@gppconline.com

Principal Investigator:

Roberto Pili, MD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • Oncology
  • Nutrition
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-04-03.