Clinical Trial: Evaluation of SAMe for Hot Flashes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes
Brief Summary:
RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its ability to potentially modulate serotonin.
PURPOSE: This phase II trial is studying the side effects and how well s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast cancer or those who do not wish to take estrogen due to a perceived increased risk of breast cancer.
Detailed Summary:
OBJECTIVES:
I. To evaluate the impact of SAMe 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.
II. To evaluate the toxicity of SAMe in this study population. III. To evaluate the effect of SAMe using quality-of-life (QOL) measures.
OUTLINE:
During the first week, participants will complete a daily, prospective hot flash diary and complete baseline questionnaires and will not be taking any study medication. After this baseline week, participants will receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
Sponsor: Mayo Clinic
Current Primary Outcome: Percent of Baseline in Average Hot Flash Activity (Score and Frequency) [ Time Frame: From baseline to week 7 ]
Original Primary Outcome: Reduction in average hot flash activity score (severity and frequency) [ Time Frame: From baseline to week 7 ]
Current Secondary Outcome:
- Change From Baseline in Self-assessment Items [ Time Frame: End of study ]
- Adverse Event Grade Incidence [ Time Frame: End of study ]
Original Secondary Outcome:
- Change From Baseline in Self-assessment Items
- Adverse Event Grade Incidence
Information By: Mayo Clinic
Dates:
Date Received: June 8, 2010
Date Started: October 2010
Date Completion:
Last Updated: April 10, 2014
Last Verified: April 2014