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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439945
Other study ID # NCCTG-N10C2
Secondary ID NCCTG-N10C2CDR00
Status Completed
Phase Phase 2
First received September 22, 2011
Last updated August 11, 2016
Start date September 2011
Est. completion date August 2013

Study information

Verified date August 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
magnesium oxide
Given PO
Other:
placebo
Given PO

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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