Low-protein diet to enhance immunotherapy effects in cancer patients

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

This study is testing whether a low-protein diet can help cancer patients on immunotherapy respond better to their treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: State University of New York at Buffalo (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT05356182 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility of a low-protein diet in cancer patients undergoing immunotherapy. Participants will be randomly assigned to receive either a standard diet with approximately 20% protein or a low-protein diet containing 10% protein while receiving immune checkpoint inhibitors. The goal is to determine if the low-protein diet can improve the immune response and enhance the anticancer effects of the treatment. This is a single-center, open-label study focused on patients with solid tumor malignancies.

Who should consider this trial

Good fit: Ideal candidates include adults with solid tumor malignancies who are eligible for immunotherapy and have a life expectancy of at least six months.

Not a fit: Patients with an ECOG performance status of 2 or higher may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for cancer patients receiving immunotherapy.

How similar studies have performed: While dietary interventions in cancer treatment are being explored, this specific low-protein approach in conjunction with immunotherapy is relatively novel.

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

Where this trial is running

Buffalo, New York

• University at Buffalo / Great Lakes Cancer Care — Buffalo, New York, United States (Recruiting)

Conditions Medical Oncology; Integrative Oncology; Medical Nutrition Therapy; Oncology; Nutrition; Immunotherapy