Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:03 AM
Study NCT ID:
NCT07420335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function After Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in C-reactive protein (CRP) level', 'timeFrame': 'Baseline (preoperative), 1 day before surgery and 1 month after surgery', 'description': 'C-reactive protein (CRP) levels will be measured to assess the postoperative inflammatory response in patients undergoing modified radical mastectomy.'}], 'secondaryOutcomes': [{'measure': 'Short Form-36 (SF-36) quality-of-life score', 'timeFrame': 'Baseline(before intervention), 1-day preoperative and 1 month after surgery', 'description': 'The Short Form-36 (SF-36) questionnaire will be used to evaluate health-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Breast Cancer (LABC)', 'Postoperative Inflammation', 'Prehabilitation']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether preoperative shoulder range-of-motion exercises influence postoperative inflammatory response, pain, shoulder function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.', 'detailedDescription': 'Breast cancer patients undergoing modified radical mastectomy are at risk of postoperative pain, shoulder dysfunction, and impaired quality of life, which may be associated with postoperative inflammatory responses. Preoperative rehabilitation strategies, including shoulder range-of-motion exercises, have been proposed to improve postoperative recovery, but evidence in patients with locally advanced breast cancer remains limited.\n\nThis study aims to evaluate the effects of a structured preoperative shoulder range-of-motion exercise program on postoperative inflammatory markers, specifically C-reactive protein (CRP), as well as pain intensity, shoulder joint function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study includes female patients diagnosed with locally advanced breast cancer undergoing modified radical mastectomy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinically locally advanced breast cancer (stage IIIA-IIIC according to the American Joint Committee on Cancer staging system) who have been scheduled to undergo modified radical mastectomy.\n* Age ≥ 18 years at the time of diagnosis\n* Willing to undergo preoperative rehabilitation for 6-8 weeks and to perform the recommended home-based exercise program.\n* Willing to participate in follow-up via telephone.\n\nExclusion Criteria:\n\n* Inability to understand verbal or written communication, resulting in difficulty following exercise instructions.\n* Intraoperative complications, such as injury to or transection of the thoracodorsal nerve, long thoracic nerve, and/or intercostobrachial nerve.\n* Postoperative complications leading to delayed wound healing, defined as incomplete wound healing at one month after surgery, including wound dehiscence, wound infection, or abscess formation.\n* Pre-existing shoulder joint motion limitation diagnosed prior to surgery (e.g., preoperative frozen shoulder).\n* Presence of inflammatory conditions in other body regions at the start of or during the study that may result in elevated leukocyte counts, such as diarrhea, urinary tract infection, or skin infection.\n* Requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids for the management of inflammation.\n\nDrop out criteria:\n\n* incomplete follow up\n* Unwillingness to undergo repeated blood sampling during the study period.'}, 'identificationModule': {'nctId': 'NCT07420335', 'briefTitle': 'Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function After Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effect of Preoperative Shoulder Range-of-Motion Exercises on C-Reactive Protein (CRP) Levels, Pain, and Shoulder Joint Dysfunction, as Well as Quality of Life in Patients With Locally Advanced Breast Cancer After Modified Radical Mastectomy', 'orgStudyIdInfo': {'id': '25-08-1282'}, 'secondaryIdInfos': [{'id': 'KET-1375/UN2.F1/ETIK/PPM.00.02', 'type': 'REGISTRY', 'domain': 'Ethical Approval from Universitas Indonesia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 : Preoperative shoulder exercise', 'description': 'Arm 1: Preoperative Shoulder Exercise Participants will receive a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy, in addition to standard preoperative care.', 'interventionNames': ['Behavioral: Preoperative shoulder exercise']}, {'type': 'OTHER', 'label': 'Arm 2 : Standard Preoperative Care', 'description': 'Arm 2: Standard Preoperative Care Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.', 'interventionNames': ['Other: Standard preoperative care']}], 'interventions': [{'name': 'Preoperative shoulder exercise', 'type': 'BEHAVIORAL', 'description': 'Arm 1 : Participants in the intervention arm will perform a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy. The exercises are designed to maintain shoulder mobility and are conducted in addition to standard preoperative care.', 'armGroupLabels': ['Arm 1 : Preoperative shoulder exercise']}, {'name': 'Standard preoperative care', 'type': 'OTHER', 'description': 'Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.', 'armGroupLabels': ['Arm 2 : Standard Preoperative Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'Dki Jakarta', 'country': 'Indonesia', 'contacts': [{'name': 'Sonar Soni Panigoro, MD, Ph.D', 'role': 'CONTACT', 'email': 'sonar.soni@ui.ac.id', 'phone': '+62-812-9502-754'}, {'name': 'Sonar Soni Panigoro, MD,Ph.D', 'role': 'CONTACT'}], 'facility': 'Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Freda S Halim, MD, Ph.D', 'role': 'CONTACT', 'email': 'freda.susana@ui.ac.id', 'phone': '+62812-99000-530'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because no formal data-sharing plan was included in the ethics-approved study protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgical Oncology Trainee', 'investigatorFullName': 'Freda Susana Halim', 'investigatorAffiliation': 'Fakultas Kedokteran Universitas Indonesia'}}}}