Phase 2
Completed N=289
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
Breast Cancer · Cancer Survivor · Hot Flashes
Source: ClinicalTrials.gov NCT01439945 ↗
Enrolled (actual)
289
Serious AEs
0.3%
Results posted
Apr 2017
Primary outcomePrimary: The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. — 16.02; 15.35; 17.28; 14.28 units on a scale — p=0.13
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. |
16.02; 15.35; 17.28; 14.28; 14.47; 15.52 | 0.13 |
| SECONDARY Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period |
8.48; 7.55; 8.89; 7.83; 7.15; 8.04 | 0.25 |
| SECONDARY Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period. |
5; 1; 2; 0; 0; 0 | — |
| SECONDARY The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination |
0; 0; 0; 0; -5; 0 | — |
| SECONDARY The Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination. |
7; 8.5 | 1.00 |
| SECONDARY The Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms. |
0.0; 0.1; 0.0 | 0.47 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01439945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.