|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 Lead Organizations/Sponsors
North Central Cancer Treatment GroupNational Cancer Institute
|Charles L. Loprinzi||Principal Investigator|
|St. Francis Hospital and Health Centers - Beech Grove Campus|
|Howard M. Gross||Ph: 765-983-3000|
|Genesys Hurley Cancer Institute|
|Philip J. Stella||Ph: 734-712-3456|
|Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital|
|Zoneddy R Dayao||Ph: 505-272-6972|
|Bismarck Cancer Center|
|John T Reynolds||Ph: 701-323-5760|
|AnMed Cancer Center|
|James Dewitt Bearden||Ph: 800-486-5941|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01439945
ClinicalTrials.gov processed this data on October 17, 2013
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