Phase 2
N=43
Evaluation of SAMe for Hot Flashes
Healthy, no Evidence of Disease · Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT01140646 ↗Enrolled (actual)
43
Serious AEs
4.4%
Results posted
Apr 2014
Primary outcome: Primary: Percent of Baseline in Average Hot Flash Activity (Score and Frequency) — 64.6; 67.4 Percent of baseline — p=0.0903
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- S-adenosyl-L-methionine disulfate p-toluene-sulfonate (Drug); questionnaire administration (Other); quality-of-life assessment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Baseline in Average Hot Flash Activity (Score and Frequency) |
64.6; 67.4 | 0.0903 |
| SECONDARY Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ) |
25; 17.5; 11.7; 10; 7.5; 2.8 | — |
| SECONDARY Change From Baseline to Week 7 for the Profile of Mood States (POMS) |
3.0; 10.9; 2.8; 2.3; 1.2; 0.7 | — |
| SECONDARY Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS) |
8.6; 13.9; 21.6; 12.8; 7.8; 5.9 | — |
| SECONDARY Number of Patients Who Reported Grade 3 Adverse Events |
2; 1 | — |
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 = = 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
Data sourced from ClinicalTrials.gov (NCT01140646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.