Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients

Conditions
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Breast Cancer, Cancer Survivor, Hot Flashes, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: magnesium oxide
* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: History of breast cancer (currently without malignant disease) No history of breast cancer but wishes to avoid estrogen due to a perceived increased risk of breast cancer Must have bothersome hot flashes (defined by their occurrence of ≥ 14 times per week and of sufficient severity to make the patient desire therapeutic intervention) for ≥ 1 month before study entry Has undergone treatment for cancer (patients other than breast cancer survivors are eligible) PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Creatinine clearance ≥ 30 mL/min No hypersensitivity to magnesium oxide No medical or other condition(s) that, in the opinion of the investigator/sub-investigator, may compromise the objectives of the study PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, progestational agents, or gabapentin More than 28 days since prior and no other concurrent investigational drugs Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed provided patient has been on a constant dose for > 4 weeks AND is not expected to stop the medication during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (magnesium oxide)<br>Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks. | Drug: magnesium oxide<br>* Given PO<br>Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (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. | from baseline to week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Quality of Life | 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. | from baseline to week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivor, hot flashes, breast cancer, unspecified adult solid tumor, protocol specific