Dietary changes to lower breast cancer risk in high-risk women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a new dietary pattern aimed at reducing breast cancer risk among postmenopausal women identified as high-risk. The intervention focuses on a low-insulinemic diet that is low in total and saturated fats, emphasizes plant-based proteins, and is rich in fruits, vegetables, whole grains, and dietary fiber. The study will assess the feasibility of implementing this dietary pattern in a clinical setting, alongside measuring changes in patient-reported outcomes and various cardiometabolic biomarkers over a 12-week period. Additionally, exploratory objectives include analyzing changes in the fecal microbiome and metabolomics related to the dietary intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Fred K Tabung, PhD, MSPH — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.