Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: 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