Breast Cancer Clinical Trial
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of 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.
Full 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 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 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.
Arm I: Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
Arm II: Patients receive a high-dose of magnesium oxide PO QD.
Arm III: Patients receive a low-dose of placebo PO QD.
Arm IV: Patients receive a high-dose of placebo PO QD. In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.
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.
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)
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There are 237 Locations for this study
Fairbanks Alaska, 99701, United States
Scottsdale Arizona, 85259, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80204, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Englewood Colorado, 80110, United States
Fort Collins Colorado, 80524, United States
Fort Collins Colorado, 80528, United States
Greeley Colorado, 80631, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
Loveland Colorado, 80539, United States
Pueblo Colorado, 81004, United States
Wheat Ridge Colorado, 80033, United States
Hartford Connecticut, 06105, United States
Daytona Beach Florida, 32114, United States
Jacksonville Florida, 32224, United States
Augusta Georgia, 30912, United States
Aiea Hawaii, 96701, United States
Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Honolulu Hawaii, 96859, United States
Kailua Hawaii, 96734, United States
Lihue Hawaii, 96766, United States
Boise Idaho, 83706, United States
Aurora Illinois, 60504, United States
Bloomington Illinois, 61701, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Eureka Illinois, 61530, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Monmouth Illinois, 61462, United States
Monmouth Illinois, 61462, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61603, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46515, United States
Indianapolis Indiana, 46237, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Plymouth Indiana, 46563, United States
Richmond Indiana, 47374, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
Westville Indiana, 46391, United States
Bettendorf Iowa, 52722, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Mason City Iowa, 50401, United States
Ottumwa Iowa, 52501, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51102, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Battle Creek Michigan, 49017, United States
Dearborn Michigan, 48123, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grosse Pointe Woods Michigan, 48236, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Monroe Michigan, 48162, United States
Monroe Michigan, 48162, United States
Muskegon Michigan, 49444, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Reed City Michigan, 49677, United States
Saginaw Michigan, 48601, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48093, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Mankato Minnesota, 56002, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
St. Paul Minnesota, 55101, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Bolivar Missouri, 65613, United States
Cape Girardeau Missouri, 63703, United States
Jefferson City Missouri, 65109, United States
Saint Louis Missouri, 63131, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68130, United States
Omaha Nebraska, 68131, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87131, United States
Hendersonville North Carolina, 28792, United States
Rutherfordton North Carolina, 28139, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Fargo North Dakota, 58102, United States
Bowling Green Ohio, 43402, United States
Chillicothe Ohio, 45601, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45420, United States
Delaware Ohio, 43015, United States
Elyria Ohio, 44035, United States
Elyria Ohio, 44035, United States
Findlay Ohio, 45840, United States
Franklin Ohio, 45005, United States
Greenville Ohio, 45331, United States
Kettering Ohio, 45429, United States
Lancaster Ohio, 43130, United States
Lima Ohio, 45804, United States
Marietta Ohio, 45750, United States
Maumee Ohio, 43537, United States
Maumee Ohio, 43537, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Oregon Ohio, 43616, United States
Oregon Ohio, 43616, United States
Portsmouth Ohio, 45662, United States
Springfield Ohio, 45505, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Troy Ohio, 45373, United States
Wauseon Ohio, 43567, United States
Westerville Ohio, 43081, United States
Wright-Patterson Afb Ohio, 45433, United States
Xenia Ohio, 45385, United States
Zanesville Ohio, 43701, United States
Tulsa Oklahoma, 74136, United States
Allentown Pennsylvania, 18105, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Anderson South Carolina, 29621, United States
Greenville South Carolina, 29601, United States
Lancaster South Carolina, 29720, United States
Rock Hill South Carolina, 29732, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57117, United States
Fredericksburg Virginia, 22401, United States
Richmond Virginia, 23298, United States
Bellingham Washington, 98225, United States
Seattle Washington, 98101, United States
Seattle Washington, 98101, United States
Seattle Washington, 98104, United States
Huntington West Virginia, 25701, United States
Eau Claire Wisconsin, 54701, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Minocqua Wisconsin, 54548, United States
Oconto Falls Wisconsin, 54154, United States
Rhinelander Wisconsin, 54501, United States
Rice Lake Wisconsin, 54868, United States
Sheboygan Wisconsin, 53081, United States
Stevens Point Wisconsin, 54481, United States
Sturgeon Bay Wisconsin, 54235, United States
Wausau Wisconsin, 54401, United States
Weston Wisconsin, 54476, United States
Wisconsin Rapids Wisconsin, 54494, United States
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