Evaluation of SAMe for Hot Flashes
Condition: Healthy, no Evidence of Disease; Hot Flashes
MeSH terms: Hot Flashes
Intervention: S-adenosyl-L-methionine disulfate p-toluene-sulfonate; questionnaire administration; quality-of-life assessment
Intervention description: Given orally; Ancillary studies; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hot flashes, dietary supplements, symptom management

Summary:

      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.
    

Eligibility criteria:

        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

          -  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

        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, 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