Status:

RECRUITING

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

Lead Sponsor:

Ohio State University Comprehensive Cancer Center

Collaborating Sponsors:

American Cancer Society, Inc.

Conditions:

Feasibility Pilot Study

Compliance

Eligibility:

FEMALE

45+ years

Phase:

NA

Brief Summary

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, thi...

Detailed Description

PRIMARY OBJECTIVE: I. Evaluate the feasibility of translating the low-Empirical Dietary Index for Hyperinsulinemia (EDIH) dietary pattern intervention from epidemiologic cohorts to the clinic in a si...

Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 45 years OR post-menopausal AND cis-gender women at study registration.
  • Overweight or World Health Organization (WHO) class 1 obese as defined by a body mass index (BMI) of 25 to 35 kg/m^2.
  • 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%.
  • Concurrent or prior use of endocrine therapy is allowed. Any dose or schedule change is not permitted for the duration of the study.
  • 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.

Exclusion Criteria:

  • Prior diagnosis of breast cancer within past 5 years.
  • Metastatic breast cancer (at study start or during study period).
  • BMI > 35 kg/m^2 or < 25 kg/m^2.
  • Pre-menopausal women or < 45 years of age.
  • Assigned male at birth.
  • 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.
  • Type 1 diabetes mellitus (DM) or insulin dependent, or evidence of brittle diabetes.
  • Presence of food allergies or intolerances to wheat, nuts, seeds, fish, or dairy foods.
  • 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.
  • Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
  • Unwilling or unable to follow protocol requirements.
  • Pregnant, trying to get pregnant, or nursing.
  • Any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study.
  • Non-English speaking, as the teaching materials and educational sessions have not yet been translated into additional languages.
  • Prisoners or other institutionalized patients.

Key Trial Info

Start Date :

October 3 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06635005

Start Date

October 3 2024

End Date

March 31 2026

Last Update

October 16 2025

Active Locations (1)

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210