A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients
OBJECTIVES:
Primary
- To determine if magnesium oxide supplement will decrease the frequency and severity of
hot flashes by 50% in menopausal women with cancer.
Secondary
- 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
supplement doses.
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.
Interventional
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
No
Thomas J. Smith, MD
Principal Investigator
Massey Cancer Center
United States: Institutional Review Board
MCC-12062
NCT01008904
July 2009
February 2014
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