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 ]

Hot flash score was defined as the number of mild hot flashes for the week plus two times the number of moderate hot flashes plus three times the number of severe hot flashes plus four times the number of very severe hot flashes. Hot flash frequency was defined as the average number of hot flashes per day for each week. Week 7 percent of baseline was calculated. The reduction in hot flash score and frequency can be calculated by subtracting the week 7 percent of baseline from 100 percent.


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