Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-03 @ 6:29 PM
Study NCT ID:
NCT03389204
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2017-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], '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': 'D018771', 'term': 'Arthralgia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were blinded to physical support or not'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT intervention and not intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-22', 'studyFirstSubmitDate': '2017-12-26', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Function of upper limb', 'timeFrame': 'six month', 'description': 'The mobility of the shoulder will be evaluates in all movements'}, {'measure': 'Complications', 'timeFrame': 'six month', 'description': 'Possible complications after surgery will be recorded'}, {'measure': 'Lymph edema', 'timeFrame': '6 mnth', 'description': 'Radius of upper limb will be measured'}, {'measure': 'physical activities influence in recovery after breast cancer surgery', 'timeFrame': '6 mnth', 'description': 'patient will be agruped by intensity and frequency of PA'}], 'primaryOutcomes': [{'measure': 'Shoulder pain', 'timeFrame': '6 mnth', 'description': 'The intensity of pain and chronological modification will be monitored'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast surgery', 'Physiotherapy', 'Breast Cancer', 'Shoulder pain', 'Shoulder motion'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '34800988', 'type': 'DERIVED', 'citation': 'Klein I, Kalichman L, Chen N, Susmallian S. A comprehensive approach to risk factors for upper arm morbidities following breast cancer treatment: a prospective study. BMC Cancer. 2021 Nov 20;21(1):1251. doi: 10.1186/s12885-021-08891-5.'}]}, 'descriptionModule': {'briefSummary': 'Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .\n\nPhysiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.\n\nThere is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.', 'detailedDescription': "Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.\n\nHypotheses\n\n* Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.\n* Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.\n\nMethods\n\nStudy design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel\n\nSample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Age 18-65.\n* Diagnosed with breast cancer, undergoing breast surgery,\n* Functional independence prior to the operation.\n* Ability to communicate in Hebrew.\n\nExclusion Criteria:\n\n* Cognitive disorders, patients unable to sign the consent form.\n* Back and spinal morbidity.\n* Fibromyalgia or chronic pain disorders.\n* Neurological disorders.\n* Renal failure with the need for dialysis.\n* Lymphedema prior to surgery.\n* History of breast surgery.\n* Shoulder surgery or shoulder injuries with limited ROM.\n* Ischemic heart disease, heart failure and radical heart insufficiency.\n* Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.'}, 'identificationModule': {'nctId': 'NCT03389204', 'briefTitle': 'Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Medical Center'}, 'officialTitle': 'Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial', 'orgStudyIdInfo': {'id': 'AMC2020-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Breast surgery and exercise', 'description': 'Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge.', 'interventionNames': ['Other: PHYSICAL THERAPY']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breast surgery and no exercise', 'description': 'Patient after breast surgery alone are discharged without exercise and instructions.', 'interventionNames': ['Other: PHYSICAL THERAPY']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breast, axilar surgery with exercise', 'description': 'Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge.', 'interventionNames': ['Other: PHYSICAL THERAPY']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breast, axillar surgery without exercise', 'description': 'The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions.', 'interventionNames': ['Other: PHYSICAL THERAPY']}], 'interventions': [{'name': 'PHYSICAL THERAPY', 'type': 'OTHER', 'description': 'EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT', 'armGroupLabels': ['Breast surgery and exercise', 'Breast surgery and no exercise', 'Breast, axilar surgery with exercise', 'Breast, axillar surgery without exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69710', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Assuta Medican Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Sergio G Susmallian, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assuta Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'February 01 2019', 'ipdSharing': 'YES', 'description': 'The patient will be evaluated after discharge by meetings or though video calls/', 'accessCriteria': 'Physiotherapy after breast cancer surgery'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of General Surgery', 'investigatorFullName': 'Sergio Gabriel Susmallian', 'investigatorAffiliation': 'Assuta Medical Center'}}}}