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Recruiting NCT05359848

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

No phase Interventional Medical Oncology Integrative Oncology Medical Nutrition Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet.
Who it may be relevant to
Registry conditions: Medical Oncology, Integrative Oncology, Medical Nutrition Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Other 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 measures

  • 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]
Secondary outcome measures (3)
  • To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction [Time frame: 12 Months]
  • To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction [Time frame: 12 Months]
  • To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction [Time frame: 12 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University at Buffalo / Great Lakes Cancer Care — Buffalo
  • University at Buffalo / Great Lakes Cancer Care — Buffalo

Identifiers

NCT: NCT05359848 · STUDY00005648

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗