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

Phase 2
18 Years
Open (Enrolling)
Healthy, no Evidence of Disease, Hot Flashes

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Trial Information

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


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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction in average hot flash activity score (severity and frequency)

Outcome Time Frame:

From baseline to week 7

Safety Issue:


Principal Investigator

Amit Sood, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease
  • Hot Flashes
  • Hot flashes, dietary supplements, symptom management
  • Hot Flashes



Mayo Clinic Rochester, Minnesota  55905