Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT06178861
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2023-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra', 'timeFrame': 'During the radiotherapy, an average of 1 month', 'description': 'Evaluating the reproducibility of breast shape through cross-correlation values in cone-beam CT and planning CT matching. This study involves comparing groups of patients wearing and not wearing a bra'}], 'secondaryOutcomes': [{'measure': 'Radiation dosimetric evaluation', 'timeFrame': 'at the time of completion of radiotherapy', 'description': 'radiation dose to lungs, heart and breast'}, {'measure': 'Patient satisfaction assessment', 'timeFrame': 'at the time of completion of radiotherapy', 'description': '1. Survey on anxiety before and after radiation treatment (using STAI, APAIS, and LASA scales)\n2. Survey on satisfaction with radiotherapy bra after radiation therapy'}, {'measure': 'Assessment of treatment toxicity', 'timeFrame': 'at 6 months and 12 months after the radiotherapy', 'description': '1. Acute toxicity grade 2 or higher according to CTCAE version 5.0\n2. Late toxicity grade 2 or higher according to CTCAE version 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Radiation Therapy']}, 'referencesModule': {'references': [{'pmid': '39952437', 'type': 'DERIVED', 'citation': 'Byun HK, Kim H, Son J, Cho Y, Kwon YJ, Kim DW, Lee H, Kim YB. Impact of bra application in breast cancer radiotherapy: A pilot prospective randomized trial. Radiother Oncol. 2025 May;206:110785. doi: 10.1016/j.radonc.2025.110785. Epub 2025 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized study investigated the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity when wearing and not wearing a bra during radiotherapy for patients with breast cancer.', 'detailedDescription': 'Post-surgery radiotherapy to the breast is standard treatment after breast-conserving surgery in patients with breast cancer. In order to apply the latest radiation therapy technologies, such as intensity-modulated radiotherapy, it is important to maintain the correct posture. However, due to the nature of the breast made of soft tissue, it is difficult to maintain the same breast shape during each treatment. This is especially difficult for large, ptotic breasts. Accordingly, we developed a bra for breast cancer patients in order to perform accurate radiotherapy. It was designed to fix the breast using bands in various directions so that its shape and position can be fixed during radiation treatment.\n\nThis is a prospective, randomized controlled study to evaluate the effects of using a bra for breast cancer patients on the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically confirmed invasive breast cancer or ductal carcinoma in situ\n2. Patients eligible for whole breast irradiation after partial mastectomy\n3. Adults over 20 years old\n4. Patients with good overall performance (ECOG PS 0-1)\n\nExclusion Criteria:\n\n1. Recurrent breast cancer patients\n2. Patients who have previously received radiation therapy to the ipsilateral breast\n3. Patients who underwent breast reconstruction\n4. Bilateral breast cancer\n5. Patients with skin diseases such as contact dermatitis'}, 'identificationModule': {'nctId': 'NCT06178861', 'briefTitle': 'Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy', 'orgStudyIdInfo': {'id': '9-2023-0052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group wearing a bra', 'description': 'Patients wear a bra while receiving radiotherapy.', 'interventionNames': ['Device: Group wearing a radiotherapy bra']}, {'type': 'NO_INTERVENTION', 'label': 'Group not wearing a bra', 'description': 'Patients do not wear a bra while receiving radiotherapy.'}], 'interventions': [{'name': 'Group wearing a radiotherapy bra', 'type': 'DEVICE', 'description': 'Group wearing a radiotherapy bra', 'armGroupLabels': ['Group wearing a bra']}]}, 'contactsLocationsModule': {'locations': [{'zip': '365', 'city': 'Yongin-si', 'country': 'South Korea', 'facility': 'Yongin Severance Hospital', 'geoPoint': {'lat': 37.29686, 'lon': 127.08042}}], 'overallOfficials': [{'name': 'Hwakyung BYUN, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hwa Kyung Byun', 'investigatorAffiliation': 'Yonsei University'}}}}