RECRUITING

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

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Medical OncologyIntegrative OncologyMedical Nutrition Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-15
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05359848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy.
  2. * Life expectancy of at least 6 months
  3. * Adults ≥ 18 years of age
  4. * Adequate hematologic, renal, and liver function as evidenced by the following:
  5. * White blood cell (WBC) ≥ 2,500 cells/μL
  6. * Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
  7. * Platelet Count ≥ 100,000 cells/μL
  8. * Hemoglobin (HgB) ≥ 9.0 g/dL
  9. * Creatinine ≤ 2.0 mg/dL
  10. * Total bilirubin ≤ 2 x upper limit of normal (ULN)
  11. * Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
  12. * Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN
  1. * • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
  2. * Treatment with any of the following medications or interventions within 28 days of registration:
  3. * Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
  4. * High dose calcitriol \[1,25(OH)2VitD\] (i.e., \> 7.0 μg/week)
  5. * Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 1 week prior to registration
  6. * A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
  7. * 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

Contacts and Locations

Study Locations (Sites)

University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, 14203
United States
University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, 14206
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-15
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2022-04-15
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Medical Oncology
  • Integrative Oncology
  • Medical Nutrition Therapy