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

Medical Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356182
• Other study ID #: STUDY00005755
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Nutrition Therapy
• Medical Oncology
• Neoplasms

Intervention

Other:
• Diet
Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Locations

Country	Name	City	State
United States	University at Buffalo / Great Lakes Cancer Care	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.	Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.	4 Months
Primary	To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.	Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.	4 Months
Secondary	To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies	Includes isolation and characterization of antigen specific T cell clones	4 Months
Secondary	To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies	Includes evaluation of antigen specific T cell populations by spectratyping T cell receptor expression	4 Months
Secondary	To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies	Includes characterization of antigen response by cytokine and chemokine production	4 Months
Secondary	To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention	Enrollment rate	4 Months
Secondary	To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention	Drop-out rate	4 Months
Secondary	To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention	Compliance with diet measured by self-report of patient	4 Months
Secondary	To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria	Objective Response Rate (ORR)	4 Months
Secondary	To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria	Progression-Free Survival (PFS)	4 Months
Secondary	To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria	Overall Survival(OS)	4 Months