Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Magnesium Oxide

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)