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Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Primary Purpose

Breast Cancer, Cancer Survivor, Hot Flashes

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
magnesium oxide
questionnaire administration
quality-of-life assessment
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring cancer survivor, hot flashes, breast cancer, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Supportive care (magnesium oxide)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 5, 2009
    Last Updated
    June 17, 2016
    Sponsor
    Virginia Commonwealth University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01008904
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Commonwealth University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supportive care (magnesium oxide)
    Arm Type
    Experimental
    Arm Description
    Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    magnesium oxide
    Intervention Description
    Given PO
    Intervention Type
    Other
    Intervention Name(s)
    questionnaire administration
    Intervention Description
    Ancillary studies
    Intervention Type
    Procedure
    Intervention Name(s)
    quality-of-life assessment
    Other Intervention Name(s)
    quality of life assessment
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)
    Description
    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 Outcome Measure Information:
    Title
    Difference in Quality of Life
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas J. Smith, MD
    Organizational Affiliation
    Massey Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21271347
    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.
    Results Reference
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    Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

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