Clinical trial NCT01140646: Evaluation of SAMe for Hot Flashes
Official title: Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy, no Evidence of Disease
Hot Flashes
Keywords: Hot flashes, dietary supplements, symptom management
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

OUTLINE:

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.

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 =\< 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, 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

Primary outcomes:
measure: Percent of Baseline in Average Hot Flash Activity (Score and Frequency)
timeFrame: From baseline to week 7
Secondary outcomes:
measure: Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
timeFrame: Baseline and Week 7
measure: Change From Baseline to Week 7 for the Profile of Mood States (POMS)
timeFrame: Baseline and Week 7
measure: Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: Baseline and Week 7
measure: Number of Patients Who Reported Grade 3 Adverse Events
timeFrame: Week 1 to Week 7
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amit Sood, M.D.
role: STUDY_CHAIR
References: