A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
Study Overview
Brief Summary
Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.
Detailed Description
This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy.
- •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)
- •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/MRI 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
Outcomes
Primary Outcomes
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
Time Frame: 12 Months
enrollment rate
Secondary Outcomes
- To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction(12 Months)
Investigators
Roberto Pili
Associate Dean for Cancer Research and Integrative Oncology
State University of New York at Buffalo