Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
NCT ID: NCT01008904
Last Updated: 2016-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2009-07-31
2013-03-31
Brief Summary
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PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
magnesium oxide
Given PO
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
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magnesium oxide
Given PO
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Thomas J. Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Massey Cancer Center
References
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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.
Other Identifiers
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HM12062
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000650938
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-01059
Identifier Type: REGISTRY
Identifier Source: secondary_id
MCC-12062
Identifier Type: -
Identifier Source: org_study_id
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