Actively Recruiting
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
Led by State University of New York at Buffalo · Updated on 2026-02-20
30
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of intermittent caloric restriction combined with a plant-based diet in cancer patients receiving chemotherapy. This pilot trial aims to assess whether this dietary approach is feasible and safe alongside standard chemotherapy, and whether it may reduce side effects while potentially enhancing the chemotherapy's antitumor effects. Participants will follow a protocol involving alternate-day intermittent caloric restriction along with a plant-based protein diet during their chemotherapy treatment. The study evaluates how this combined dietary intervention interacts with standard chemotherapy regimens over the course of treatment. During the study, participants will be monitored for adherence to the dietary plan and chemotherapy treatment. Researchers will assess feasibility over 12 months, including safety and preliminary evidence of clinical efficacy. Evaluations may include health assessments, laboratory tests, and monitoring of side effects throughout the study period.
CONDITIONS
Brief Title
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed cancer patients eligible for cytotoxic chemotherapy
- Life expectancy of at least 6 months
- Adults 18 years of age or older
- Adequate blood and organ function including:
- White blood cell count ≥ 2,500 cells/µL
- Absolute neutrophil count ≥ 1,000 cells/µL
- Platelet count ≥ 100,000 cells/µL
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 2 times upper limit of normal
- AST (SGOT) ≤ 2.5 times upper limit of normal
- ALT (SGPT) ≤ 2.5 times upper limit of normal
You will not qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher
- Treatment with systemic corticosteroids within 28 days prior to registration (inhaled, intranasal, and topical steroids allowed)
- Use of high dose calcitriol (> 7.0 µg/week) within 28 days prior to registration
- Infection requiring parenteral antibiotic therapy or fever (> 100.5°F or 38.1°C) within 1 week prior to registration
- Allergy, intolerance, or medical contraindication to contrast dye needed for CT/MRI imaging
- Any medical condition or intervention that could affect study adherence or objectives as judged by the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive intermittent caloric restriction combined with a plant-based diet alongside standard chemotherapy.
Visits aligned with chemotherapy schedule, typically multiple visits over treatment duration
Trial Site Locations
Total: 2 locations
1
University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, United States, 14203
Actively Recruiting
2
University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, United States, 14206
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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