Overview
Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
Status:
Completed
Completed
Trial end date:
2013-03-01
2013-03-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Virginia Commonwealth UniversityTreatments:
Magnesium Oxide
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