Breast Cancer
Conditions
Brief summary
This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.
Interventions
Changing to low glycemic diet
Sponsors
Study design
Eligibility
Inclusion criteria
* Are between 40 and 60 years of age * Still menstruating with at least 10 menstrual cycles in the previous 12 months * Not Taking hormone replacement therapy * Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period) * Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia * No history of breast augmentation or reduction surgery * Have no history of any other malignancy (excluding non-melanoma skin cancer) in the previous 5 years * Have no history of diabetes or other metabolic diseases requiring dietary modification * Have a study baseline mammographic density of at least 50% as estimated by mammographer * BIRADS 1 or 2 mammogram if first ever mammogram, otherwise stable mammogram (no change since previous year) * Have not followed a weight reduction or Atkins typs diet in the past 6 months Not pregnant or lactating in the past 12 months, nor intending pregnancy during the study period * Successful completion of three baseline telephone-administered 24- hour dietary recalls
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diet Change | 2 years | To Assess the feasibility of a randomized trial to achieve diet change and promote longterm adoption of a low glycemic index diet intervention among women at high risk for breast cancer (\> 50% of breast area occupied by radiological density) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | 4, 8 & 12 months on Treatment | To estimate the effect of a low glycemic index diet on breast cancer related biomarkers, including those associated with carbohydrate, growth and steroid hormaone metabolism and mammograhic density. Result from this aim will provide important preliminary data for use in planning a larger clinical trial. |
Countries
United States