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

NCT05359848 | Recruiting

• 1 other identifier: STUDY00005648
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction

  12 Months

• To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction

  12 Months

• To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction

  12 Months

Other Outcomes (1)

• The safety and tolerability of the combination of chemotherapy and caloric restriction

  12 Months

Interventions

Diet OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (2)

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, 14203, United States

RECRUITING

University at Buffalo / Great Lakes Cancer Care

Buffalo, New York, 14206, United States

RECRUITING

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Cancer Research and Integrative Oncology

Model Details: Patients with cancer where SOC is represented by chemotherapy will be eligible for the study. After informed consent, eligible patients will be scheduled to the chemotherapy. Each cycle will be every 14, 21 or 28 days depending on the regimen. The diet intervention will commence 1 week prior to the first infusion (i.e. on Day -5 for regimens every 21-28 days, on Day-3 for regimens every 14 days) and will continue until the end of cycle 4 or 6 depending on the regimen in the neoadjuvant or adjuvant setting. For metastatic disease the dietary intervention will last until cycle 6 and not beyond

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 4, 2022
• Study Start: April 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (2)