Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-03-14 @ 2:36 AM
Study NCT ID:
NCT01896050
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2013-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'C056516', 'term': 'exemestane'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'norahh@med.umich.edu', 'phone': '734-936-4991', 'title': 'Norah Lynn Henry, MD', 'organization': 'University of Michigan Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'only unexpected serious adverse events were collected', 'eventGroups': [{'id': 'EG000', 'title': 'AI Therapy', 'description': 'Subjects who started treatment with any of the three aromatase inhibitor (AI) medications', 'otherNumAtRisk': 93, 'otherNumAffected': 37, 'seriousNumAtRisk': 93, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Tamoxifen', 'description': 'Subjects who started treatment with tamoxifen', 'otherNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'symptom leading to treatment discontinuation', 'notes': 'For expected toxicities, we only collected information about whether a patient felt her symptoms were bothersome enough to stop treatment, not treatment about the individual symptoms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'death', 'notes': 'one patient died during study participation of reasons unrelated to study participation or AI therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AI Therapy', 'description': 'Subjects who started treatment with any of the three aromatase inhibitor (AI) medications'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Subjects who started treatment with tamoxifen'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '5.70', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '6.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Compare difference in change in body mass index between baseline and 12 months between aromatase inhibitor- and tamoxifen-treated patients', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4262', 'groupIds': ['OG000'], 'paramType': 'BMI squared', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.01845', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02308', 'groupDescription': "Examine association between change in body mass index and change in grip strength with aromatase inhibitor therapy. For the primary outcome, linear regression was used for analysis with change of grip strength as response variable. In the original statistical analysis plan only aromatase inhibitor-treated patients were to be included in this analysis. This analysis was not performed on the tamoxifen group because it isn't clinically relevant.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'Change in BMI between baseline and 12 months of endocrine therapy', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These data only include patients who completed a full 12 months of treatment with either an aromatase inhibitor or tamoxifen and had grip strength data at both baseline and 12 months. Patients could have switched from one aromatase inhibitor to another. Those patients who discontinued treatment prior to the 12 month period were excluded.'}, {'type': 'SECONDARY', 'title': 'Effect of Medication on Change in Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AI Therapy', 'description': 'Subjects who started treatment with any of the three aromatase inhibitor (AI) medications'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Subjects who started treatment with tamoxifen'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of change in maximum grip strength between baseline and 12 months for aromatase inhibitor-treated versus tamoxifen-treated patients', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromatase Inhibitor', 'description': 'Aromatase inhibitor-treated patients'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Tamoxifen-treated patients'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.04', 'groupDescription': 'Association between baseline body mass index and discontinuation of aromatase inhibitor therapy. The original statistical analysis plan only called for analyzing the aromatase inhibitor-treated patients, not the tamoxifen-treated patients.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 12 months', 'description': 'Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AI Therapy', 'description': 'Subjects who started treatment with any of the three aromatase inhibitor (AI) medications'}, {'id': 'FG001', 'title': 'Tamoxifen', 'description': 'Subjects who started treatment with tamoxifen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'This includes only patients who remained on the same aromatase inhibitor medication for 12 months', 'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AI Therapy', 'description': 'Subjects who started treatment with any of the three aromatase inhibitor (AI) medications'}, {'id': 'BG001', 'title': 'Tamoxifen', 'description': 'Subjects who started treatment with tamoxifen'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '79'}, {'value': '61.5', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '69'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body-mass index', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '29', 'spread': '7', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist-hip ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '0.09', 'groupId': 'BG000'}, {'value': '0.92', 'spread': '0.12', 'groupId': 'BG001'}, {'value': '0.91', 'spread': '0.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maximum grip strength, right hand', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kPa', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maximum grip strength, left hand', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '53.7', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kPa', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average pain', 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Patients reported pain on a 0-10 visual analog scale, with 0 being no pain and 10 being worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood is being collected at baseline for DNA extraction. Serum is being collected at baseline and after 3, 6, and 12 months.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2013-07-05', 'resultsFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2013-07-05', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-06', 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy', 'timeFrame': 'baseline and 12 months', 'description': 'Change in BMI between baseline and 12 months of endocrine therapy'}], 'secondaryOutcomes': [{'measure': 'Effect of Medication on Change in Grip Strength', 'timeFrame': 'baseline and 12 months', 'description': 'Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months'}, {'measure': 'Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months', 'timeFrame': 'baseline and 12 months', 'description': 'Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Joint pain', 'Grip strength', 'Hormone receptor positive breast cancer'], 'conditions': ['Breast Cancer', 'Arthralgia', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 0-III breast cancer who are scheduled to receive endocrine therapy with tamoxifen or an aromatase inhibitor\n* All prior surgery and chemotherapy should be complete\n* Age 18 and above and postmenopausal\n\nExclusion Criteria:\n\n* Major rheumatologic disorders\n* Concomitant sex hormone containing drugs or Leutinizing Hormone Releasing Hormone agonist therapy\n* For those subjects initiating treatment with an aromatase inhibitor, prior tamoxifen within 4 weeks of enrollment\n* For those subjects initiating treatment with tamoxifen, prior aromatase inhibitor within 4 weeks of enrollment'}, 'identificationModule': {'nctId': 'NCT01896050', 'acronym': 'LOGRIBMET', 'briefTitle': 'Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen', 'orgStudyIdInfo': {'id': 'UMCC 2009.029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AI therapy', 'description': 'Subjects who started treatment with any of the three aromatase inhibitor (AI) medications', 'interventionNames': ['Drug: anastrozole, letrozole, exemestane']}, {'label': 'Tamoxifen', 'description': 'Subjects who started treatment with tamoxifen', 'interventionNames': ['Drug: Tamoxifen']}], 'interventions': [{'name': 'anastrozole, letrozole, exemestane', 'type': 'DRUG', 'otherNames': ['Arimidex, Femara, Aromasin'], 'description': 'Patients were treated with one of the listed anti-hormonal medications for up to one year', 'armGroupLabels': ['AI therapy']}, {'name': 'Tamoxifen', 'type': 'DRUG', 'otherNames': ['Novaldex'], 'description': 'Patients were treated with tamoxifen for up to one year', 'armGroupLabels': ['Tamoxifen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Norah L Henry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lynn Henry', 'investigatorAffiliation': 'University of Michigan Rogel Cancer Center'}}}}