Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05356182 | RECRUITING | Medical Oncology

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

State University of New York at Buffalo

Information provided by (Responsible Party):

Roberto Pili

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.

Condition or disease

Medical Oncology

Integrative Oncology

Medical Nutrition Therapy

Intervention/treatment

Diet

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Pilot and Feasibility Study of a Dietary Intervention with Low-protein Meals in Cancer Patients Receiving Immunotherapies
Actual Study Start Date : 2022-05-04
Estimated Primary Completion Date : 2025-04
Estimated Study Completion Date : 2025-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Pilot and Feasibility Study of a Dietary Intervention with Low-protein Meals in Cancer Patients Receiving Immunotherapies

Location Details

NCT05356182

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, United States, 14203