Evaluation of SAMe for Hot Flashes

Completed · Phase 2

Conditions studied: Healthy, no Evidence of Disease, Hot Flashes

In brief

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.

Key facts

Study ID

NCT01140646

Run by

Mayo Clinic

People needed

45

Starts

2010-10-01

Expected to finish

2012-11-01

Last updated by the study team

2019-01-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer
• Bothersome hot flashes (defined by their occurrence >= 14 times per week and of sufficient severity to make the patient desire therapeutic intervention)
• Presence of hot flashes for >= 1 month prior to registration
• Life expectancy >= 6 months
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
• Ability to complete questionnaire(s) by themselves or with assistance
• Negative pregnancy test done =< 7 days prior to registration for women of childbearing potential only

You may not qualify if…

• Any of the following current (=< last 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for >= 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy, vitamin E, flaxseed, and megadose vitamins (herbal teas, multivitamins, and vitamin D are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency), medications interacting with SAMe (antidepressants, monoamine oxidase (MAO) inhibitors, meperidine, dextromethorphan, pentazocine, tramadol, gabapentin, and levodopa)
• Pregnant women
• Nursing women
• Women of childbearing potential who are unwilling to employ adequate contraception
• Known allergy to SAMe
• Current use or use within the past 6 months of SAMe
• Clinically significant acute or chronic progressive or unstable neurologic, psychiatric, hepatic, renal, cardiovascular, respiratory, metabolic, or systemic disease precluding participation in the study
• History of bipolar disorder or Parkinsonism

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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