Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Cancer Survivor; Hot Flashes; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: magnesium oxide; Other: questionnaire administration; Procedure: quality-of-life assessment

• Registration Number: NCT01008904
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

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 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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Results First Submitted: 2013-08-12
• Results First Submitted QC: 2013-12-17
• Results First Posted: 2014-02-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (magnesium oxide)	questionnaire administration	Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Supportive care (magnesium oxide)	magnesium oxide	Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Supportive care (magnesium oxide)	quality-of-life assessment	Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)	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.

Secondary Outcome Measures

Name	Time	Method
Difference in Quality of Life	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.