Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-01 @ 9:54 PM
Study NCT ID:
NCT01008904
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2009-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008277', 'term': 'Magnesium Oxide'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsmit136@jhmi.edu', 'phone': '410-955-2091', 'title': 'Thomas J. Smith, MD', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Study start to study completion. (5 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Supportive Care (Magnesium Oxide)', 'description': 'Patients receive magnesium oxide PO QD or BID for 4 weeks.', 'otherNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}], 'seriousEvents': [{'term': 'Surgery', 'notes': 'unrelated due to seroma involving the left breast flap, after bilateral TRAM flap', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Magnesium Oxide)', 'description': 'Patients receive magnesium oxide PO QD or BID for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.4', 'spread': '40.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 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.', 'unitOfMeasure': 'percentage of difference', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '25 patients completed the complete study and were analyzed'}, {'type': 'SECONDARY', 'title': 'Difference in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Magnesium Oxide)', 'description': 'Patients receive magnesium oxide PO QD or BID for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to week 5', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supportive Care (Magnesium Oxide)', 'description': 'Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'unexpected unrelated surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'We enrolled female patients with bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention for ≥ 1 month prior to study entry) after undergoing treatment for cancer. Patients were recruited from the Massey Cancer Center oncology clinics.', 'preAssignmentDetails': 'Of the 31 patients enrolled, 29 received treatment. 25 completed treatment and were analyzed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Supportive Care (Magnesium Oxide)', 'description': 'Patients receive magnesium oxide PO QD or BID for 4 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '3.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'patient who started study treatment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2009-11-05', 'resultsFirstSubmitDate': '2013-08-12', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-17', 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)', 'timeFrame': 'from baseline to 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.'}], 'secondaryOutcomes': [{'measure': 'Difference in Quality of Life', 'timeFrame': 'from baseline to week 5', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer survivor', 'hot flashes', 'breast cancer', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Breast Cancer', 'Cancer Survivor', 'Hot Flashes', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '21271347', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.\n\nPURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer.\n\nSecondary\n\n* To evaluate the effect of magnesium oxide on overall quality of life.\n* To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses.\n\nOUTLINE: 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.\n\nPatients 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.\n\nAfter completion of study treatment, patients are followed up for at least 30 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * History of breast cancer (currently without malignant disease)\n * No history of breast cancer but wishes to avoid estrogen due to a perceived increased risk of breast cancer\n* 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\n* Has undergone treatment for cancer (patients other than breast cancer survivors are eligible)\n\nPATIENT CHARACTERISTICS:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Creatinine clearance ≥ 30 mL/min\n* No hypersensitivity to magnesium oxide\n* No medical or other condition(s) that, in the opinion of the investigator/sub-investigator, may compromise the objectives of the study\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, progestational agents, or gabapentin\n* More than 28 days since prior and no other concurrent investigational drugs\n* 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'}, 'identificationModule': {'nctId': 'NCT01008904', 'briefTitle': 'Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients', 'orgStudyIdInfo': {'id': 'MCC-12062'}, 'secondaryIdInfos': [{'id': 'HM12062', 'type': 'OTHER', 'domain': 'VCU IRB'}, {'id': 'CDR0000650938', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-2012-01059', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (magnesium oxide)', 'description': 'Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.', 'interventionNames': ['Drug: magnesium oxide', 'Other: questionnaire administration', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'magnesium oxide', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Supportive care (magnesium oxide)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (magnesium oxide)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (magnesium oxide)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas J. Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massey Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}