Flaxseed for the Treatment of Hot Flashes
Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its capacity to safely and effectively treat hot flashes. Specifically, this study seeks to determine if flaxseed will lower the number and severity of hot flashes and if women experience any side effects from taking flaxseed for this purpose.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Flaxseed for the Treatment of Hot Flashes|
- Determine if flaxseed will lower the number and severity of hot flashes
- Determine if there are any side effects from taking flaxseed for hot flashes
- Evaluate the impact of flaxseed on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
- Evaluate the toxicity of flaxseed in this study population.
- Evaluate the effect of flaxseed on quality-of-life measures.
|Study Start Date:||May 2005|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275704
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Sandhya Pruthi, M.D.||Mayo Clinic|