Phase 2
N=29
Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
Breast Cancer · Cancer Survivor · Hot Flashes · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT01008904 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Feb 2014
Primary outcome: Primary: Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5) — -50.4 percentage of difference
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- magnesium oxide (Drug); questionnaire administration (Other); quality-of-life assessment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5) |
-50.4 | — |
| SECONDARY Difference in Quality of Life |
0.14 | — |
Summary
RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.
PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- History of breast cancer (currently without malignant disease)
- No history of breast cancer but wishes to avoid estrogen due to a perceived increased risk of breast cancer
- Must have bothersome hot flashes (defined by their occurrence of ≥ 14 times per week and of sufficient severity to make the patient desire therapeutic intervention) for ≥ 1 month before study entry
- Has undergone treatment for cancer (patients other than breast cancer survivors are eligible)
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine clearance ≥ 30 mL/min
- No hypersensitivity to magnesium oxide
- No medical or other condition(s) that, in the opinion of the investigator/sub-investigator, may compromise the objectives of the study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, progestational agents, or gabapentin
- More than 28 days since prior and no other concurrent investigational drugs
- Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed provided patient has been on a constant dose for > 4 weeks AND is not expected to stop the medication during the study period
Data sourced from ClinicalTrials.gov (NCT01008904). 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.