Status:
RECRUITING
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Medical Oncology
Integrative Oncology
Eligibility:
All Genders
18+ years
Phase:
NA
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 st...
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 ...
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
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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
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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
-
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05356182
Start Date
May 4 2022
End Date
February 1 2028
Last Update
April 3 2026
Active Locations (1)
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1
University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, United States, 14203