RECRUITING

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

Conditions

Medical Oncology Integrative Oncology Medical Nutrition Therapy Oncology Nutrition Immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-04

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05356182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* • 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

Inclusion Criteria

Exclusion 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

* • 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

Contacts and Locations

Study Locations (Sites)

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, 14203

United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-04

Study Completion Date2025-04

Study Record Updates

Study Start Date2022-05-04

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

Oncology
Nutrition
Immunotherapy

Additional Relevant MeSH Terms

Medical Oncology
Integrative Oncology
Medical Nutrition Therapy