Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Virginia Commonwealth University31 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

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

Interventions

magnesium oxideDRUG

Given PO

questionnaire administrationOTHER

Ancillary studies

quality-of-life assessmentPROCEDURE

Ancillary studies

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: from baseline to week 5

Secondary Outcomes

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.

Time frame: from baseline to week 5

Data from ClinicalTrials.gov

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