Hot Flashes Clinical Trial
Official title:
Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes
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.
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.
;
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