NCT01276704

Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Carol Fabian, MD · Academic / Other
• Sex: Female
• Age: 21 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.

Detailed description

The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles. The investigators would also like to determine if Brevail® can reduce breast cell proliferation in pre-menopausal women.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Placebo	The placebo contains same filler materials as commercially available Brevail® but without active SDG.
DRUG	secoisolariciresinol	1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg

Timeline

• Start date: 2011-01-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2011-01-13
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

7 sites across 1 country: United States