Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
Condition: Breast Cancer; Cancer Survivor; Hot Flashes
MeSH terms: Breast Neoplasms; Hot Flashes
Intervention: magnesium oxide; placebo
Intervention description: Given PO; Given PO
Intervention MeSH terms: Magnesium Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 289.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hot flashes; cancer survivor; breast cancer

Summary:

      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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Women with a history of breast cancer (currently without malignant disease)

          -  Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of
             sufficient severity to make the patient desire therapeutic intervention)

          -  Presence of hot flashes for ≥ 30 days prior to study registration

          -  Willingness to provide the biologic specimens as required by the protocol

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Women who are postmenopausal as defined by absence of a period in the past 12 months
             or bilateral oophorectomy

               -  Women with at least one ovary but without a uterus should be deemed
                  postmenopausal by either age over 55 or a combination of estrogen within a
                  postmenopausal range (per local lab) and FSH over 40 mIU/mL

               -  No women of childbearing potential or who are premenopausal

          -  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):

               -  Antineoplastic chemotherapy (trastuzumab or lapatinib are allowed)

               -  Androgens

               -  Estrogens (any delivery route)

               -  Progestational agents

          -  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)