Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 9:59 AM
Study NCT ID:
NCT01223833
Status:
COMPLETED
Last Update Posted:
2013-07-25
First Post:
2010-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitors and Tamoxifen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018771', 'term': 'Arthralgia'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of BMI on loss of grip strength measured by a modified sphygmomanometer with baseline, month 3, month 6 and month 12 measurements.', 'timeFrame': '1 year', 'description': 'measurements occur at baseline, 3 months, 6 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'IGF-I, GH and IGFBP-3 levels', 'timeFrame': '1 year', 'description': 'Serum levels of IGF-I, GH and IGFBP-3 will be measured at baseline, 3, 6 and 12 months after start of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'postmenopausal', 'aromatase inhibitors', 'tamoxifen', 'arthralgia', 'IGF-I', 'BMI', 'grip strength'], 'conditions': ['Breast Cancer', 'Arthralgia']}, 'descriptionModule': {'briefSummary': 'The Logribmet study is a prospective study that evaluate grip strength changes in both hands of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase inhibitor. Patients included in the study will undergo a grip strength measurement and receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6 months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a predictor for the decrease in grip strength.\n\nIGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal early breast cancer patients scheduled to start adjuvant hormonal therapy with any of the third generation aromatase inhibitors or tamoxifen in University Hospitals Leuven.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with early breast cancer who are scheduled to receive endocrine therapy with tamoxifen or any of the third-generation aromatase inhibitors, anastrozole, letrozole or exemestane.\n2. No major rheumatological disorders such as severe rheumatoid arthritis.\n3. Patients must have provided informed consent for participation in this study.\n\nExclusion Criteria:\n\n1. Concomitant endocrine therapy for breast cancer.\n2. Concomitant intake of sex hormone containing drugs such as hormone replacement therapy.'}, 'identificationModule': {'nctId': 'NCT01223833', 'acronym': 'LOGRIBMET', 'briefTitle': 'A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitors and Tamoxifen', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, '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': 'S51575'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'tamoxifen', 'description': '100 postmenopausal women with early breast cancer treated with tamoxifen in the adjuvant setting'}, {'label': 'aromatase inhibitors', 'description': '200 postmenopausal women with early breast cancer treated with an aromatase inhibitor in the adjuvant setting'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Patrick Neven, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}