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

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether a new type of diet can help reduce the risk of breast cancer in women who are considered high-risk. The diet focuses on foods that lead to lower insulin levels in the blood, which may be linked to a reduced risk of various cancers. It includes less fat and animal protein, and encourages eating more fruits, vegetables, whole grains, and plant-based proteins. The researchers want to see if this dietary approach is practical and effective for women who are at higher risk for breast cancer.

To participate in this study, women need to be at least 45 years old or post-menopausal and have a body mass index (BMI) between 25 and 35, which indicates they are overweight or mildly obese. They must also be considered high-risk for breast cancer based on medical guidelines. Participants will receive guidance on this new diet and will be monitored throughout the study. It’s important to note that certain medical conditions, recent illnesses, or dietary restrictions may exclude individuals from joining the trial.

Gender

FEMALE

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.