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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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210