Intermittent caloric restriction and plant-based diet for cancer patients undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the feasibility of combining intermittent caloric restriction with a plant-based diet in cancer patients receiving chemotherapy. The study aims to determine if this dietary approach can enhance the effectiveness of chemotherapy while reducing its side effects. Participants will follow an intermittent caloric restriction protocol on alternate days prior to chemotherapy administration. The trial will assess the safety and potential benefits of this combined dietary intervention in improving patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University at Buffalo / Great Lakes Cancer Care
  Buffalo, New York, United States Recruiting
• University at Buffalo / Great Lakes Cancer Care
  Buffalo, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.