Recruiting

Intermittent Caloric Restriction & Plant-based Diet

Sponsor:

State University of New York at Buffalo

Code:

NCT05359848

Conditions

Medical Oncology

Integrative Oncology

Medical Nutrition Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet

Study Details

Brief 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.

Conditions

Medical Oncology

Integrative Oncology

Medical Nutrition Therapy

Study ID

NCT05359848

Start date

Apr 15, 2022

Status verified date

Feb, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Diet

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

Primary outcome measure

  • The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy [ Time Frame: 12 Months ]
  • The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy [ Time Frame: 12 Months ]
  • The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy [ Time Frame: 12 Months ]

Central Contacts and Locations

Locations

University at Buffalo / Great Lakes Cancer Care

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ashlee Lang, MPH

716-860-0267alang@kaleidahealth.org

Kyle Pasquariello, MA

716-529-6470kpasquariello@gppconline.com

Principal Investigator:

Roberto Pili, MD

University at Buffalo / Great Lakes Cancer Care

Recruiting

Buffalo, New York, United States, 14206

Contacts

Ashlee Lang, MPH

716-860-0267alang@kaleidahealth.org

Kyle Pasquariello, MA

716-529-6470kpasquariello@gppconline.com

Principal Investigator:

Roberto Pili, MD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-02-20.