RECRUITING

A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women

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 clinical trial tests whether a new dietary pattern that consists of foods that lower the blood insulin response can reduce breast cancer risk in high-risk women. In a large group of patients, this new dietary pattern was associated with reduced risk of multiple cancers and reduced risk of long-term weight gain. Parts of this new dietary pattern are quite different from typical dietary recommendations, and much education is needed. Overall, compared to the typical American diet, this new dietary pattern is moderately low in total fat and saturated fat, low in protein from animal foods but high in protein from plant sources, high in fruits and vegetables, high in whole grains, and high in dietary fiber. We will determine if a low-insulinemic dietary pattern intervention is feasible and effective in reducing breast cancer risk in high-risk women.

Official Title

A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women

Quick Facts

Study Start:2024-10-03
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06635005

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:45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 45 years OR post-menopausal AND cis-gender women at study registration.
  2. * Overweight or World Health Organization (WHO) class 1 obese as defined by a body mass index (BMI) of 25 to 35 kg/m\^2.
  3. * High risk for breast cancer at the discretion of the physician, using standard definitions such as a Gail 5-year risk of ≥ 2% or Tyrer Cuzick version (v) 8.0 10-year risk of ≥ 5%.
  4. * Concurrent or prior use of endocrine therapy is allowed. Any dose or schedule change is not permitted for the duration of the study.
  5. * Currently established care or previously seen at the Ohio State University Comprehensive Cancer Center (OSUCCC) Stefanie Spielman Comprehensive Breast Center (SSCBC) high risk breast clinic.
  1. * Prior diagnosis of breast cancer within past 5 years.
  2. * Metastatic breast cancer (at study start or during study period).
  3. * BMI \> 35 kg/m\^2 or \< 25 kg/m\^2.
  4. * Pre-menopausal women or \< 45 years of age.
  5. * Assigned male at birth.
  6. * Uncontrolled intercurrent illness including lung disease, heart disease, metabolic disease; exacerbations for disease in past 8 weeks; unstable on medications for chronic conditions in past 6 weeks. This could affect compliance and engagement with study intervention. Change in anti-hyperglycemic or lipid lowering medications is best avoided for the duration of the study unless deemed necessary by treating provider or required for acute exacerbation of existing illness.
  7. * Type 1 diabetes mellitus (DM) or insulin dependent, or evidence of brittle diabetes.
  8. * Presence of food allergies or intolerances to wheat, nuts, seeds, fish, or dairy foods.
  9. * Currently on special diet for known metabolic or gastrointestinal disease, or planning to start a specific dietary regimen such as vegetarian, vegan, ketogenic, low-fat diets, etc.
  10. * Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
  11. * Unwilling or unable to follow protocol requirements.
  12. * Pregnant, trying to get pregnant, or nursing.
  13. * Any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study.
  14. * Non-English speaking, as the teaching materials and educational sessions have not yet been translated into additional languages.
  15. * Prisoners or other institutionalized patients.

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Fred K Tabung, PhD, MSPH
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Fred K Tabung, PhD, MSPH, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer 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 Date2024-10-03
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-10-03
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Insulinemic dietary pattern, high-risk, breast cancer, cardiometabolic health

Additional Relevant MeSH Terms

  • Feasibility Pilot Study
  • Compliance