A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of breast cancer.
PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a history of breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to age (18-49 years vs ≥ 50 years), current tamoxifen and/or selective estrogen receptor modulator (yes vs no), current aromatase inhibitor (yes vs no), and daily frequency of hot flashes (4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.
Some patients may continue or crossover to receive magnesium for 4 more weeks.
Patients complete the Hot Flash Diary daily for 9 weeks beginning 1 week before treatment. They also complete the Symptom Experience Questionnaire, the Profile of Mood States (POMS), and Hot Flash-Related Daily Interference Scale (HFRDIS) questionnaires periodically during study treatment.
Patients undergo blood sample collection at baseline and at the end of weeks 5 and 9 for serum magnesium level analysis.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Women who are postmenopausal as defined by absence of a period in the past 12 months or bilateral oophorectomy
Creatinine clearance > 30 mL/min
Ability to complete questionnaire(s) by themselves or with assistance
ECOG performance status 0 or 1
No history of allergic or other adverse reaction to magnesium
No diabetes
No patients with conditions that are implicated in decreased absorption of magnesium (e.g., Crohn disease, ETOH abuse)
No patients who have diarrhea where magnesium might make it worse (per provider discretion)
PRIOR CONCURRENT THERAPY:
None of the following current (≤ 28 days prior to registration) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for ≥ 28 days and must not be expected to stop the medication during the study period):
No prior use of magnesium for hot flashes
No current or planned use of gabapentin (for any reasons) or antidepressants (for any reasons) or other agents for treating hot flashes (except stable dose of vitamin E is allowed as long as it was started > 30 days prior to study registration and are to be continued through the study period; soy is allowed, if it is planned to be continued at the same dose during the study period)
No current use of magnesium for any indication (except one standard multiple vitamin dose is allowed per day)
Not taking diuretics, corticosteroids, bile acid sequestrants, and other prescription and over-the-counter medications that may affect magnesium levels
No current (≤ 7 days prior to registration) or planned use of other non-drug therapies for managing hot flashes, such as acupuncture or yoga (use of these therapies for other reasons is allowed)
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