Spots Global Cancer Trial Database for Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
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Trial Identification
Brief Title: Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
Study ID: NCT01439945
Study Description
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 magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a history of breast cancer.
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 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
St. Anthony Central Hospital, Denver, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Front Range Cancer Specialists, Fort Collins, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Herbert D. Kerman Regional Oncology Center - Daytona Beach, Daytona Beach, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Kapiolani Medical Center at Pali Momi, Aiea, Hawaii, United States
Oncare Hawaii, Incorporated - Pali Momi, Aiea, Hawaii, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana, Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated, Honolulu, Hawaii, United States
Kuakini Medical Center, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
Castle Medical Center, Kailua, Hawaii, United States
Kauai Medical Clinic, Lihue, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Illinois CancerCare - Bloomington, Bloomington, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare - Canton, Canton, Illinois, United States
Illinois CancerCare - Carthage, Carthage, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Illinois CancerCare - Eureka, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Illinois CancerCare - Havana, Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare - Macomb, Macomb, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States
, Moline, Illinois, United States
Illinois CancerCare - Monmouth, Monmouth, Illinois, United States
OSF Holy Family Medical Center, Monmouth, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Illinois CancerCare - Pekin, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare - Peru, Peru, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Illinois CancerCare - Princeton, Princeton, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
St. Francis Hospital Cancer Care Services, Indianapolis, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States
Reid Hospital & Health Care Services, Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States
, Bettendorf, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, Clive, Iowa, United States
Mercy Cancer Center - West Lakes, Clive, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan, United States
Mercy General Health Partners, Muskegon, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Spectrum Health Reed City Hospital, Reed City, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
MeritCare Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Immanuel St. Joseph's, Mankato, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Clinic - River Campus, Saint Cloud, Minnesota, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Regions Hospital Cancer Care Center, St. Paul, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology - Woodbury, Woodbury, Minnesota, United States
Central Care Cancer Center at Carrie J. Babb Cancer Center, Bolivar, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Healthcare Cancer Care, Butte, Montana, United States
Benefis Sletten Cancer Institute, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States
Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Lovelace Medical Center - Downtown, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Park Ridge Hospital, Hendersonville, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, United States
Mid Dakota Clinic, PC, Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center, Bismarck, North Dakota, United States
MeritCare Broadway, Fargo, North Dakota, United States
Wood County Oncology Center, Bowling Green, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Mount Carmel Hospital East, Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Medical Center Cancer Care, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Community Cancer Center, Elyria, Ohio, United States
Hematology Oncology Center, Elyria, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Northwest Ohio Oncology Center, Maumee, Ohio, United States
St. Luke's Hospital, Maumee, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Toledo Clinic - Oregon, Oregon, Ohio, United States
Southern Ohio Medical Center Cancer Center, Portsmouth, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
St. Anne Mercy Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States
United States Air Force Medical Center - Wright-Patterson, Wright-Patterson Afb, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
AnMed Cancer Center, Anderson, South Carolina, United States
Bon Secours St. Francis Health System, Greenville, South Carolina, United States
Carolina Blood and Cancer Care Associates, PA, Lancaster, South Carolina, United States
Carolina Blood and Cancer Care, Rock Hill, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Pacific Medical Center, Seattle, Washington, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, United States
St. Nicholas Hospital, Sheboygan, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Marshfield Clinic - Wausau Center, Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Charles L. Loprinzi, MD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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