Dietary changes to lower breast cancer risk in high-risk women
A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women
This study is testing a new diet designed to lower breast cancer risk in postmenopausal women who are at high risk to see if it helps improve their health and well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06635005 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 45 and older who are overweight or class 1 obese and have a high risk for breast cancer.
Not a fit: Patients with a prior diagnosis of breast cancer within the last 5 years or those who are pre-menopausal will not benefit from this study.
Why it matters
Potential benefit: If successful, this dietary intervention could significantly lower breast cancer risk for high-risk women.
How similar studies have performed: While dietary interventions have been explored in cancer prevention, this specific low-insulinemic dietary approach is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.