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

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

This study tests if a mix of eating less on some days and following a plant-based diet can help cancer patients on chemotherapy feel better and get more benefit from their treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: State University of New York at Buffalo (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Buffalo, New York and 1 other locations)
• Trial ID: NCT05359848 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically documented cancer who are eligible for cytotoxic chemotherapy and have a life expectancy of at least 6 months.

Not a fit: Patients with an ECOG performance status of 2 or higher or those who have received certain medications within 28 days prior to registration may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the effectiveness of chemotherapy and reduce its side effects for cancer patients.

How similar studies have performed: While this approach is innovative, similar studies exploring dietary interventions in cancer treatment have shown promising results, suggesting potential for success.

Eligibility criteria

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 this trial is running

Buffalo, New York and 1 other locations

• 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)

Conditions: Medical Oncology, Integrative Oncology, Medical Nutrition Therapy