Integrative Oncology, Medical Nutrition Therapy, Medical Oncology
Conditions
Keywords
Oncology, Nutrition, Immunotherapy
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.
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).
Interventions
OTHERDiet
Control diet consisting of 20% protein, intervention diet consisting of 10% protein
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. | 4 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies | 4 Months | Includes isolation and characterization of antigen specific T cell clones |
| To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention | 4 Months | Enrollment rate |
| To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention | 4 Months | Drop-out rate |
| To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention | 4 Months | Compliance with diet measured by self-report of patient |
| 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 | 4 Months | Objective Response Rate (ORR) |
Countries
United States
Outcome results
None listed