RECRUITING

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

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Conditions

Cancer, OvarianChemotherapy EffectCalorie DeficiencyFasting, IntermittentFasting mimicking dietGynecologic malignancyChemotherapy

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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

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

Official Title

Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies

Quick Facts

Study Start:2021-09-08
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06376604

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:35 Years to 70 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women
  2. * Age 35-70 years old (both inclusive)
  3. * Biopsy proven gynecologic malignancy
  4. * Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
  5. * BMI greater than or equal to 18.5
  6. * Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
  7. * Willing to adhere to a 5-day fasting mimicking diet
  1. * Pregnant or nursing mothers
  2. * Prisoners
  3. * Patients with diabetes or history of hypoglycemia
  4. * Taking daily medications that cannot be safely taken without food
  5. * History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
  6. * Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
  7. * Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.

Contacts and Locations

Study Contact

Min Wei, PhD
CONTACT
323.791.2426
mwei@l-nutra.com
Jonathan D Boone, MD
CONTACT
8653055622
jboone@utmck.edu

Principal Investigator

Jonathan D Boone
PRINCIPAL_INVESTIGATOR
The University of Tennessee Medical Center

Study Locations (Sites)

The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States

Collaborators and Investigators

Sponsor: L-Nutra Inc

  • Jonathan D Boone, PRINCIPAL_INVESTIGATOR, The University of Tennessee Medical Center

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 Date2021-09-08
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-09-08
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Fasting mimicking diet
  • Gynecologic malignancy
  • Chemotherapy

Additional Relevant MeSH Terms

  • Cancer, Ovarian
  • Chemotherapy Effect
  • Calorie Deficiency
  • Fasting, Intermittent