Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
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|ClinicalTrials.gov Identifier: NCT01008904|
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : February 5, 2014
Last Update Posted : June 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cancer Survivor Hot Flashes Unspecified Adult Solid Tumor, Protocol Specific||Drug: magnesium oxide Other: questionnaire administration Procedure: quality-of-life assessment||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||March 2013|
Experimental: Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Drug: magnesium oxide
Other: questionnaire administration
Procedure: quality-of-life assessment
Other Name: quality of life assessment
- Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5) [ Time Frame: from baseline to week 5 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008904
|Principal Investigator:||Thomas J. Smith, MD||Massey Cancer Center|