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|
- Difference in hot flash activity (score) between baseline and week 5 [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]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
- Difference in quality of life [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]Difference in quality of life measured using Linear Analogue Self-Assessment (LASA) Quality of Life Questionnaire
- Toxicity and adverse events [ Time Frame: up to 30 days post treatment ] [ Designated as safety issue: Yes ]Toxicity and adverse events categorized according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. We will analyze the toxicities in a descriptive manner.
- Difference in self-assessment scale score [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]We will analyze the self-reported side effects in a descriptive manner.
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||February 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (magnesium oxide)
Patients receive magnesium oxide PO QD or BID 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 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.