Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
Basic Trial Information
|Phase II||Supportive care||Closed||18 and over||NCI, Other||N10C2|
NCCTG-N10C2, CDR0000711021, NCI-2011-03537, NCT01439945
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.
Further Study Information
- Evaluate the efficacy of magnesium oxide on hot flashes in women with a history of breast cancer.
- 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.
- 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
- 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)
- 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)
Trial Contact Information
Trial Lead Organizations/Sponsors
North Central Cancer Treatment Group
- National Cancer Institute
St. Francis Hospital and Health Centers - Beech Grove Campus
Howard M. Gross
Genesys Hurley Cancer Institute
Philip J. Stella
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Zoneddy R Dayao
Bismarck Cancer Center
John T Reynolds
AnMed Cancer Center
James Dewitt Bearden
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01439945
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.