Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer, Cancer, Cancer, Hot Flash |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/13/2016 |
Start Date: | September 2011 |
End Date: | August 2013 |
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.
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.
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.
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.
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)
We found this trial at
285
sites
Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
Click here to add this to my saved trials
1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
(610) 402-8000
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Lehigh Valley Hospital provides a...
Click here to add this to my saved trials
3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
Click here to add this to my saved trials
1719 East 19th Avenue
Denver, Colorado 80218
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
Click here to add this to my saved trials
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
Click here to add this to my saved trials
1 Saint francis dr
Greenville, South Carolina 29601
Greenville, South Carolina 29601
(864) 255-1000
Bon Secours St. Francis Health System This 245-bed, all-private-room facility is located near downtown Greenville,...
Click here to add this to my saved trials
19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
Click here to add this to my saved trials
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
Click here to add this to my saved trials
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
Click here to add this to my saved trials
Kapiolani Medical Center at Pali Momi Pali Momi Medical Center is a nonprofit hospital located...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
Click here to add this to my saved trials
5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
Click here to add this to my saved trials
1120 15th Street, BAA-5407
Augusta, Georgia 30912
Augusta, Georgia 30912
(706) 721-2505
MBCCOP - Medical College of Georgia Cancer Center The Georgia Regents University (GRU) is located...
Click here to add this to my saved trials
Aurora Presbyterian Hospital At The Medical Center of Aurora and Centennial Medical Plaza, we treat...
Click here to add this to my saved trials
Click here to add this to my saved trials
300 North Ave
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
Click here to add this to my saved trials
St. Joseph Cancer Center The PeaceHealth St. Joseph Cancer Center offers a full-range of services...
Click here to add this to my saved trials
MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1101 N 27th St # 201
Billings, Montana 59101
Billings, Montana 59101
(406) 237-3585
St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
Click here to add this to my saved trials
2900 12th Ave N Ste 160W
Billings, Montana 59101
Billings, Montana 59101
(406) 238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
Click here to add this to my saved trials
720 E Rosser Ave
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
Click here to add this to my saved trials
900 East Broadway
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
701.530.7000
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
Click here to add this to my saved trials
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
Click here to add this to my saved trials
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
Click here to add this to my saved trials
St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
Click here to add this to my saved trials
1055 N Curtis Rd
Boise, Idaho 83706
Boise, Idaho 83706
(208) 367-2121
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Saint Alphonsus Health System...
Click here to add this to my saved trials
1501 North Oakland Drive
Bolivar, Missouri 65613
Bolivar, Missouri 65613
417-326-7200
Central Care Cancer Center at Carrie J. Babb Cancer Center Cancer treatment often requires a...
Click here to add this to my saved trials
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
Click here to add this to my saved trials
Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
Click here to add this to my saved trials
Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
Click here to add this to my saved trials
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
Click here to add this to my saved trials
St. James Healthcare Cancer Care The St. James Cancer Center is an integrated cancer treatment...
Click here to add this to my saved trials
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
Click here to add this to my saved trials
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
Click here to add this to my saved trials
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
Click here to add this to my saved trials
701 10th St SE
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
(319) 365-4673
Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
Click here to add this to my saved trials
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
Click here to add this to my saved trials
Mercy Cancer Center - West Lakes When it comes to cancer care, there
Click here to add this to my saved trials
Click here to add this to my saved trials
2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
(719) 776-5000
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
Click here to add this to my saved trials
Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
Click here to add this to my saved trials
11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
Click here to add this to my saved trials
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
Click here to add this to my saved trials
Click here to add this to my saved trials
18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
Click here to add this to my saved trials
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
Click here to add this to my saved trials
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
Click here to add this to my saved trials
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
Click here to add this to my saved trials
St. Anthony Central Hospital The St. Anthony Medical Campus in Lakewood combines our heritage of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
Click here to add this to my saved trials
300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
Click here to add this to my saved trials
1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
Click here to add this to my saved trials
1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
Click here to add this to my saved trials
411 Laurel St New Visions
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3970
Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
Click here to add this to my saved trials
1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
Click here to add this to my saved trials
411 Laurel Street
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
Click here to add this to my saved trials
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
Click here to add this to my saved trials
Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
Click here to add this to my saved trials
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
Click here to add this to my saved trials
Community Cancer Center When you have cancer, you might think first of treatments
Click here to add this to my saved trials
Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
Click here to add this to my saved trials
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
Click here to add this to my saved trials
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
Click here to add this to my saved trials
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
Click here to add this to my saved trials
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
Click here to add this to my saved trials
Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
550 Osborne Road
Fridley, Minnesota 55432
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
Click here to add this to my saved trials