Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: magnesium oxide
Other: questionnaire administration
Procedure: quality-of-life assessment
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients|
- Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5) [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]Hot flash score (frequency x severity) at baseline was compared to the end of treatment. The number of flashes in a 24 hour day and a score combining the number and severity of hot flashes (ie, 1 point for mild, 2 points for moderate, 3 points for severe and 4 points for very severe.
- Difference in Quality of Life [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]Mayo Clinic Uniscale instrument (6 questions with each question rating 0=as bad as it can be and 10=as good as it can be). A lower score is considered to be a better outcome.
|Study Start Date:||July 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Drug: magnesium oxide
Given POOther: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessment
- 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 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.