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Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008904
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : February 5, 2014
Last Update Posted : June 21, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer Survivor Hot Flashes Unspecified Adult Solid Tumor, Protocol Specific Drug: magnesium oxide Other: questionnaire administration Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients
Study Start Date : July 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Drug: magnesium oxide
Given PO

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Primary Outcome Measures :
  1. Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5) [ Time Frame: 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 :
  1. Difference in Quality of Life [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008904

Sponsors and Collaborators
Virginia Commonwealth University
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Principal Investigator: Thomas J. Smith, MD Massey Cancer Center
Publications of Results:
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Responsible Party: Virginia Commonwealth University Identifier: NCT01008904    
Other Study ID Numbers: MCC-12062
HM12062 ( Other Identifier: VCU IRB )
CDR0000650938 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-01059 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Posted: November 6, 2009    Key Record Dates
Results First Posted: February 5, 2014
Last Update Posted: June 21, 2016
Last Verified: June 2016
Keywords provided by Virginia Commonwealth University:
cancer survivor
hot flashes
breast cancer
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Hot Flashes
Magnesium Oxide
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents