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

NCT ID: NCT05359848Sponsor: State University of New York at BuffaloLast updated: 2026-02-20

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.

Arms & interventions

  • OtherDiet

    Using dietary interventions as an adjuvant tool may represent an effective step toward advancing the treatment options of cancer. Dietary modifications can impact the growth and proliferation of tumors via multiple mechanisms

Outcome measures

Primary

  • The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy

    enrollment rate

    Time frame: 12 Months

  • The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy

    drop-out rate

    Time frame: 12 Months

  • The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy

    compliance with diet measured by self-reports

    Time frame: 12 Months

Secondary

  • To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction

    Time frame: 12 Months

  • To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction

    Time frame: 12 Months

  • To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction

    Time frame: 12 Months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (2)

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, 14203

Recruiting
Ashlee Lang, MPH · Contact
Kyle Pasquariello, MA · Contact
Roberto Pili, MD · Principal Investigator

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, 14206

Recruiting
Ashlee Lang, MPH · Contact
Kyle Pasquariello, MA · Contact
Roberto Pili, MD · Principal Investigator
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy | Cancerify