Clinical trial NCT01008904: Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
Official title: A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Cancer Survivor
Hot Flashes
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: cancer survivor
hot flashes
breast cancer
unspecified adult solid tumor, protocol specific
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)
timeFrame: from baseline to week 5
Secondary outcomes:
measure: Difference in Quality of Life
timeFrame: from baseline to week 5
Other outcomes:
Locations:
Study officials:
affiliation: Massey Cancer Center
name: Thomas J. Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park H, Parker GL, Boardman CH, Morris MM, Smith TJ. A pilot phase II trial of magnesium supplements to reduce menopausal hot flashes in breast cancer patients. Support Care Cancer. 2011 Jun;19(6):859-63. doi: 10.1007/s00520-011-1099-7. Epub 2011 Jan 27.