A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy

Recruiting now · Not applicable

Conditions studied: Medical Oncology, Integrative Oncology, Medical Nutrition Therapy

In brief

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.

Key facts

Study ID

NCT05359848

Run by

State University of New York at Buffalo

People needed

30

Starts

2022-04-15

Expected to finish

2027-06-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• University at Buffalo / Great Lakes Cancer Care — Buffalo, New York, United States (enrolling)
• University at Buffalo / Great Lakes Cancer Care — Buffalo, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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