Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 2

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

Treatments: Drug: magnesium oxide; Other: questionnaire administration; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01008904

NCI-2012-01059 (Registry Identifier)

HM12062 (Other Identifier)

CDR0000650938 (Registry Identifier)

MCC-12062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

Supportive care (magnesium oxide)

Experimental group

Description:

Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.

Treatment:

Drug: magnesium oxide

Procedure: quality-of-life assessment

Other: questionnaire administration