Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Sep 22, 2011
Trial Information
Current as of June 10, 2025
Completed
Keywords
ClinConnect Summary
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 study population.
* Evaluate the effect of magnesium oxide on the secondary outcomes hot flash frequencies, hot flash severities, toxicities (including diarrhea), and hot flash-related daily interference on activities.
* Evaluate the effect of magnesium oxide on the change of magnesium level (for the first 150 patients).
OUTLINE: This is a multicenter study. Patients are stratified according to ag...
Gender
FEMALE
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)
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jacksonville, Florida, United States
Rochester, Minnesota, United States
Spartanburg, South Carolina, United States
Flint, Michigan, United States
Urbana, Illinois, United States
Saint Louis Park, Minnesota, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
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Flint, Michigan, United States
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Burnsville, Minnesota, United States
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Minneapolis, Minnesota, United States
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Clive, Iowa, United States
Hendersonville, North Carolina, United States
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Patients applied
Trial Officials
Charles L. Loprinzi, MD
Principal Investigator
Mayo Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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