Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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, 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