Status:
COMPLETED
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Cancer Survivor
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 magnes...
Detailed Description
OBJECTIVES: Primary * Evaluate the efficacy of magnesium oxide on hot flashes in women with a history of breast cancer. Secondary * Evaluate the side-effect profile of magnesium oxide in this stud...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT01439945
Start Date
September 1 2011
End Date
August 1 2013
Last Update
April 4 2017
Active Locations (283)
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1
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
3
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
4
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019