Ensayos clínicos

Inclusion Criteria

• Female
• History of breast cancer (currently without malignant disease) 
• Has no history of breast cancer but wishes 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) alone or with assistance
• Negative pregnancy test done ≤ 7 days prior to registration for women of childbearing potential only

Exclusion Criteria

• Any of the following current (≤ last 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but must have been 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