Status:
COMPLETED
Evaluation of SAMe for Hot Flashes
Lead Sponsor:
Mayo Clinic
Conditions:
Healthy, no Evidence of Disease
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 we...
Detailed Description
OBJECTIVES: 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 cance...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01140646
Start Date
October 1 2010
End Date
November 1 2012
Last Update
January 31 2019
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905