Clinical trial · Interventional
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
NCT01439945CI-TRIAL-00026775completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Survivor | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| magnesium oxide | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
- interventionNames
- Drug: magnesium oxide
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive a high-dose of magnesium oxide PO QD.
- interventionNames
- Drug: magnesium oxide
- type
- PLACEBO_COMPARATOR
- label
- Arm III
- description
- Patients receive a low-dose of placebo PO QD.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.