A Study to Evaluate S-Adenosyl-L-Methionine for the Treatment of Hot Flashes

Overview

About this study

 

The purpose of this study is to assess the side effects and effectiveness of s-adenosyl-L-methionine for treating hot flashes in women who have a history of breast cancer or who do not wish to take estrogen due to a perceived increased risk of breast cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Debra Barton, Ph.D., R.N.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20312636

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