Recruiting NCT05356182
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet.
- Who it may be relevant to
- Registry conditions: Medical Oncology, Integrative Oncology, Medical Nutrition Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Diet
Control diet consisting of 20% protein, intervention diet consisting of 10% protein
Primary outcome measures
- To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. [Time frame: 4 Months]
- To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. [Time frame: 4 Months]
Secondary outcome measures (9)
- To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies [Time frame: 4 Months]
- To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies [Time frame: 4 Months]
- To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies [Time frame: 4 Months]
- To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention [Time frame: 4 Months]
- To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention [Time frame: 4 Months]
- To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention [Time frame: 4 Months]
- 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 [Time frame: 4 Months]
- 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 [Time frame: 4 Months]
- 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 [Time frame: 4 Months]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University at Buffalo / Great Lakes Cancer Care — Buffalo
Identifiers
NCT: NCT05356182 · STUDY00005755