Breast Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
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.
Status | Completed |
Enrollment | 288 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan |
United States | Kapiolani Medical Center at Pali Momi | Aiea | Hawaii |
United States | Oncare Hawaii, Incorporated - Pali Momi | Aiea | Hawaii |
United States | Lovelace Medical Center - Downtown | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | Aurora Presbyterian Hospital | Aurora | Colorado |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
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 | Illinois CancerCare - Bloomington | Bloomington | Illinois |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Central Care Cancer Center at Carrie J. Babb Cancer Center | Bolivar | Missouri |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Wood County Oncology Center | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Illinois CancerCare - Canton | Canton | Illinois |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Illinois CancerCare - Carthage | Carthage | Illinois |
United States | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa |
United States | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center - West Lakes | Clive | Iowa |
United States | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Mount Carmel Hospital East | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Herbert D. Kerman Regional Oncology Center - Daytona Beach | Daytona Beach | Florida |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | St. Anthony Central Hospital | Denver | Colorado |
United States | St. Joseph Hospital | Denver | Colorado |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Lutheran Hospital | 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 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Elkhart Clinic, LLC | Elkhart | Indiana |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Michiana Hematology-Oncology, PC - Elkhart | Elkhart | Indiana |
United States | Community Cancer Center | Elyria | Ohio |
United States | Hematology Oncology Center | Elyria | Ohio |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | Illinois CancerCare - Eureka | Eureka | Illinois |
United States | Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks | Alaska |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Front Range Cancer Specialists | Fort Collins | Colorado |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Galesburg Clinic, PC | Galesburg | Illinois |
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 | Benefis Sletten Cancer Institute | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | 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 | Bon Secours St. Francis Health System | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Illinois CancerCare - Havana | Havana | Illinois |
United States | Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania |
United States | St. Peter's Hospital | Helena | Montana |
United States | Park Ridge Hospital | Hendersonville | North Carolina |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Kuakini Medical Center | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Kuakini | 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 | Tripler Army Medical Center | Honolulu | Hawaii |
United States | Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | St. Francis Hospital Cancer Care Services | Indianapolis | Indiana |
United States | Dickinson County Healthcare System | Iron Mountain | Michigan |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Carolina Blood and Cancer Care Associates, PA | Lancaster | South Carolina |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Cancer Center of Kansas, PA - Liberal | Liberal | Kansas |
United States | Kauai Medical Clinic | Lihue | Hawaii |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Cancer Resource Center - Lincoln | Lincoln | Nebraska |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
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 | Illinois CancerCare - Macomb | Macomb | Illinois |
United States | Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin |
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 | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa |
United States | Northwest Ohio Oncology Center | Maumee | Ohio |
United States | St. Luke's Hospital | Maumee | Ohio |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin |
United States | Michiana Hematology-Oncology, PC - South Bend | Mishawaka | Indiana |
United States | Saint Joseph Regional Medical Center | Mishawaka | Indiana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois |
United States | Illinois CancerCare - Monmouth | Monmouth | Illinois |
United States | OSF Holy Family Medical Center | Monmouth | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Mercy General Health Partners | Muskegon | Michigan |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin |
United States | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Immanuel Medical Center | Omaha | Nebraska |
United States | Lakeside Hospital | Omaha | Nebraska |
United States | St. Charles Mercy Hospital | Oregon | Ohio |
United States | Toledo Clinic - Oregon | Oregon | Ohio |
United States | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | Illinois CancerCare - Pekin | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare - Peru | Peru | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | Michiana Hematology Oncology PC - Plymouth | Plymouth | Indiana |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Southern Ohio Medical Center Cancer Center | Portsmouth | Ohio |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Illinois CancerCare - Princeton | Princeton | Illinois |
United States | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin |
United States | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
United States | Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Carolina Blood and Cancer Care | Rock Hill | South Carolina |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | CentraCare Clinic - River Campus | Saint Cloud | Minnesota |
United States | Coborn Cancer Center | Saint Cloud | Minnesota |
United States | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan |
United States | Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
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 | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | CCOP - Virginia Mason Research Center | Seattle | Washington |
United States | Pacific Medical Center | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota |
United States | St. Nicholas Hospital | Sheboygan | Wisconsin |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | Regions Hospital Cancer Care Center | St. Paul | Minnesota |
United States | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | St. Anne Mercy Hospital | Toledo | Ohio |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | Munson Medical Center | Traverse City | Michigan |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Marshfield Clinic - Wausau Center | Wausau | Wisconsin |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Methodist West Hospital | West Des Moines | Iowa |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Michiana Hematology Oncology PC - La Porte | Westville | Indiana |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
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 | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology - Woodbury | Woodbury | Minnesota |
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 |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The intra-patient changes of weekly hot flash activity from baseline during the treatment period | Up to 13 weeks | No | |
Secondary | The change of weekly frequency and maximum grade of hot flashes as measured by the Hot Flash Diary during the treatment period | Up to 13 weeks | No | |
Secondary | The change of frequency and maximum grade of adverse events reported via the CTCAE 4.0 during the treatment period, in particular, diarrhea | Up to 13 weeks | Yes | |
Secondary | The change of severity of symptoms as measured the Symptom Experience Questionnaire from baseline to treatment termination | Up to 13 weeks | No | |
Secondary | The change of mood as measured by the POMS from baseline to treatment termination | Up to 13 weeks | No | |
Secondary | The change of daily interference as measured by the HFRDIS from baseline to treatment termination | Up to 13 weeks | No | |
Secondary | The intra-patient changes of weekly hot flash activity from baseline during the treatment period between two placebo groups using different dosing | Up to 13 weeks | No | |
Secondary | The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms and whether it is correlated with hot flash activity level and change | Up to 13 weeks | No |
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