Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-03 @ 1:56 AM
Study NCT ID:
NCT06859593
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2025-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Extremity Exercise Capacity Of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper Extremity Exercise Capacity', 'timeFrame': 'One Year', 'description': '6-Minute Pegboard and Ring Test'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Upper Extremity Functionality', 'timeFrame': 'One Year', 'description': 'Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) The score ranges from 0 to 100. A higher score reflects more severe upper extremity dysfunction, and the cutoff scores are 0-15 for normal, 16-40 for having problems but working, and more than 40 for being unable to work'}, {'measure': 'Lymphedema Evaluation', 'timeFrame': 'One Year', 'description': 'Arm circumference measurement'}, {'measure': 'Measurement of arm length, arm and forearm circumference', 'timeFrame': 'One Year', 'description': "The circumference and length measurements of the participants' dominant and non-dominant arm will be measured using a tape measure"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'upper extremity', '6-minute pegboard and ring test', 'exercise capacity'], 'conditions': ['Breast Cancer Survivor', 'Healty Controls']}, 'descriptionModule': {'briefSummary': 'Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. Although survival can be improved with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are common during and/or after breast cancer treatments. In addition, lymphedema can cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity.', 'detailedDescription': "Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. While the breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently observed during and/or after breast cancer treatments. Upper extremity lymphedema that develops after breast cancer treatment usually affects the glenohumeral joint by increasing the tension in the tendons of the rotator cuff muscles and disrupting the scapulohumeral rhythm. In addition, lymphedema may cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity. Kinesiophobia (fear-avoidance reaction to activity), which may develop in patients in relation to the affected extremity, is another factor in decreased capacity of the upper extremity. Patients may restrict the use of their extremities to prevent aggravation of lymphedema. Decreased functional capacity is common after breast cancer treatment. The '6 Minute Pegboard and Ring Test-6PBRT' is a valid and reliable, useful, practical and easy-to-administer test that evaluates unsupported arm endurance in breast cancer patients, patients with COPD, patients with asthma and healthy individuals. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried for 6 minutes is recorded as a score. In a study conducted in patients with mild to very severe COPD, it was shown that there was a positive correlation between the 6PBRT score and activity counts assessed by accelerometry. In addition, the 6PBRT score showed a clear relationship with upper extremity ROM and it was concluded that the 6PBRT test can be used as a suitable test for predicting and demonstrating improvement of ROM in pulmonary rehabilitation programs. Therefore, the aim of this study was to test both arm endurance and arm exercise capacity of patients with breast cancer using the 6PBRT test and to compare them with healthy individuals to understand how much they are affected compared to healthy individuals.\n\nAs a secondary aim of the study, it is planned to investigate the relationship between lymph edema severity and anthropometric measurements and upper extremity activities and arm exercise capacity in the group with breast cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18-65 years who are diagnosed with breast cancer at Hacettepe University Hospital, Department of Internal Medicine, Division of Medical Oncology, and who volunteer to participate in the study will be included in the study. For healthy groups, age and gender appropriate volunteers will be recruited for the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBreast Cancer Group:\n\n1. Being between 18-65 years of age,\n2. Volunteering to participate in the research,\n3. Stage I-III breast cancer,\n4. At least 15 months after breast cancer surgery,\n5. Six months after active breast cancer treatment (i.e. surgery/chemotherapy),\n6. No problems in reading and/or understanding the scales and being able to cooperate with the tests,\n\nHealthy group:\n\n1. Age between 18-65 years,\n2. Volunteering to participate in the research,\n3. No problems in reading and/or understanding the scales and being able to cooperate with the tests.\n\nExclusion Criteria:\n\nBreast Cancer Group:\n\n1. Presence of active infection,\n2. Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,\n3. Having a neurological disease or other clinical diagnosis that may affect cognitive status.\n\nHealthy group:\n\n1. Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance,\n2. Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests'}, 'identificationModule': {'nctId': 'NCT06859593', 'briefTitle': 'Upper Extremity Exercise Capacity Of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Comparison Of Upper Extremity Exercise Capacity Of Breast Cancer Patients With Healthy Individuals', 'orgStudyIdInfo': {'id': 'FTREK 25/01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Group', 'description': 'Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status.', 'interventionNames': ['Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test']}, {'label': 'Control Group', 'description': 'The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests.', 'interventionNames': ['Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test']}], 'interventions': [{'name': 'Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Upper Extremity Exercise Capacity', 'armGroupLabels': ['Breast Cancer Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'State', 'country': 'Turkey (Türkiye)', 'facility': 'Hcettepe University, Ankara, State 06100', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Melda Saglam, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ebru Calik Kutukcu', 'investigatorAffiliation': 'Hacettepe University'}}}}