A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients
- To determine if magnesium oxide supplement will decrease the frequency and severity of
hot flashes by 50% in menopausal women with cancer.
- To evaluate the effect of magnesium oxide on overall quality of life.
- To evaluate the effect of magnesium oxide on other drugs used.
- To evaluate the toxicities of magnesium oxide when administered at commonly used
OUTLINE: Patients receive oral magnesium oxide once daily in weeks 2-5. Patients whose hot
flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium
oxide twice daily in weeks 4 and 5.
Patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment.
Patients also complete quality-of-life, symptom, and self-assessment questionnaires at
baseline, once weekly during treatment, and at the completion of treatment.
After completion of study treatment, patients are followed up for at least 30 days.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Difference in hot flash activity (score) between baseline and week 5
Plots will provided of hot flash scores over the 5 week period. Descriptive statistics for the hot flash measurements will be provided. A longitudinal repeated measures analysis using generalized linear models (GLM) methods will be applied to analyze the hot flash
from baseline to week 5
Thomas J. Smith, MD
Massey Cancer Center
United States: Institutional Review Board