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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 10-001896
    NCT ID: NCT01140646
    Sponsor Protocol Number: MC09C4

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

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

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CLS-20312636

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