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

University at Buffalo (UB)

Status

Enrolling

Conditions

Integrative Oncology

Medical Nutrition Therapy

Medical Oncology

Treatments

Other: Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05359848

STUDY00005648

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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