Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT03383835
Brief Summary:
This pilot study is an investigation of feasibility of moderate dose omega-3 fatty acid supplementation in pre-menopausal women at high risk for breast cancer who are considering future pregnancy. The goal of this pilot study is to determine feasibility of the study, document compliance with omega-3 fatty acid supplementation in this population and identify novel biomarkers modulated by moderate dose omega-3 fatty acids in this population.
Detailed Description:
Pregnancy and breast feeding are protective when they occur at an early age, typically at an age less than 30. The influence of pregnancy on breast cancer risk is not fully understood, and little is known about modulation of the breast microenvironment during pregnancy and its influence on risk. Hormones, including rising estrogen levels, play a role in fatty acid synthesis. In pre-clinical models, a rise in omega-3:omega-6 ratio occurs naturally in the breast of pregnant mice. This may be able to be accentuated in human breast tissue with omega-3 fatty acid supplementation. Omega-3 fatty acid supplementation has been shown to favorably modulate breast cancer risk and risk biomarkers in pre-menopausal women at high risk for breast. Omega-3 fatty acid supplementation during pregnancy has also been found to have positive outcomes for the offspring, making it an ideal intervention to study in this population.
This pilot study of omega-3 supplementation in pre-menopausal women at high risk for breast cancer who are still considering pregnancy is addressing a potential prevention strategy in a population otherwise excluded from breast cancer prevention trials and not eligible for standard of care chemoprevention. With this pilot, the intent is to establish feasibility, document tolerability, determine number of women needed to enroll based on pregnancy rate and identify biomarkers for future investigation. This information will provide necessary data to apply for future extramural funding for a larger randomized trial. In a larger randomized trial with longer follow up, we will be able to assess post-pregnancy breast tissue and biomarkers to examine efficacy of omega-3 fatty acid supplementation in breast cancer risk reduction.
Study:
NCT03383835
Study Brief:
Protocol Section:
NCT03383835