Evaluation of SAMe for Hot Flashes (SAMe)
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|ClinicalTrials.gov Identifier: NCT01140646|
Recruitment Status : Completed
First Posted : June 9, 2010
Results First Posted : April 11, 2014
Last Update Posted : April 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy, no Evidence of Disease Hot Flashes||Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate Other: questionnaire administration Procedure: quality-of-life assessment||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Arm I
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then 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.
Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate
Other Name: SAMe disulfate p-toluene-sulfonateOther: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessment
- 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.
- Change From Baseline in Self-assessment Items [ Time Frame: End of study ]
- Adverse Event Grade Incidence [ Time Frame: End of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140646
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Amit Sood, M.D.||Mayo Clinic|