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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Medical Oncology; Integrative Oncology; Medical Nutrition Therapy
• Intervention / Treatment: Other: Diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo / Great Lakes Cancer Care
      • Contact: Ashlee Lang, MPH; Phone Number: 716-860-0267; Email: alang@kaleidahealth.org
      • Contact: Kyle Pasquariello, MA; Phone Number: 716-529-6470; Email: kpasquariello@gppconline.com
      • Principal Investigator: Roberto Pili, MD
    • Buffalo, New York, United States, 14206
      • Recruiting
      • University at Buffalo / Great Lakes Cancer Care
      • Contact: Ashlee Lang, MPH; Phone Number: 716-860-0267; Email: alang@kaleidahealth.org
      • Contact: Kyle Pasquariello, MA; Phone Number: 716-529-6470; Email: kpasquariello@gppconline.com
      • Principal Investigator: Roberto Pili, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy	enrollment rate	12 Months
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy	drop-out rate	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	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction	objective response rate (partial + complete response)	12 Months
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction	progression-free survival (PFS)	12 Months
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction	overall survival (OS)	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety and tolerability of the combination of chemotherapy and caloric restriction	assessed using NCI CTCAE	12 Months

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet
• Other Study ID Numbers: STUDY00005648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No