Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-25 @ 7:32 AM
Study NCT ID:
NCT02881203
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2016-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Breathe Well', 'timeFrame': '2 years', 'description': "The accuracy will be measured by comparing 'Breathe Well' and RPM measurements with images acquired of the breast during the radiation treatment using an electronic portal imaging device (EPID)."}], 'secondaryOutcomes': [{'measure': 'Difference in set up times for Breathe Well vs RPM', 'timeFrame': '2 years', 'description': "The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions."}, {'measure': 'Patient comfort', 'timeFrame': '2 years', 'description': "To investigate patient comfort in using 'Breathe Well' via a patient survey."}, {'measure': 'Staff perception of Breathe Well', 'timeFrame': '2 years', 'description': "To investigate staff perception of 'Breathe Well' via a technology assessment survey."}, {'measure': 'To develop the use of EPID for real time MLC tracking during breast radiotherapy', 'timeFrame': '2 years'}, {'measure': 'To compare actual and planned doses', 'timeFrame': '2 years', 'description': 'Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'radiation', 'DIBH', 'cardiac toxicity'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36814310', 'type': 'DERIVED', 'citation': 'Byrne HL, Steiner E, Booth J, Lamoury G, Morgia M, Richardson K, Ambrose L, Makhija K, Stanton C, Zwan B, Bromley R, Atyeo J, Silvester S, Plant N, Keall P. BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy. Trials. 2023 Feb 22;24(1):132. doi: 10.1186/s13063-023-07072-y.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold.', 'detailedDescription': 'Recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. For patients diagnosed \\<50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. The deep inspiration breath hold (DIBH) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. Providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the DIBH technique by 95% and stability by 80%.\n\nBreathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Left-sided breast cancer patients (invasive and in situ)\n* Supine positioning of the patients.\n* Ability to perform a ≥20s breath hold\n* \\>18 years old\n* An ECOG score in the range of 0 to 2\n* Able to give written informed consent and willingness to participate and comply with the study\n* Patients must be able to read and complete questionnaires in English\n\nExclusion Criteria:\n\n* Involvement or at risk regional lymph nodes\n* Pregnant / lactating women'}, 'identificationModule': {'nctId': 'NCT02881203', 'acronym': 'BRAVEHeart', 'briefTitle': 'Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart', 'orgStudyIdInfo': {'id': 'BRAVEHeartV1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breathe Well + RPM', 'description': 'Participants will receive Breathe Well audiovisual feedback in addition to the RPM system', 'interventionNames': ['Device: Breathe Well', 'Device: RPM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RPM', 'description': "Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.", 'interventionNames': ['Device: RPM']}], 'interventions': [{'name': 'Breathe Well', 'type': 'DEVICE', 'description': 'Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.', 'armGroupLabels': ['Breathe Well + RPM']}, {'name': 'RPM', 'type': 'DEVICE', 'description': 'Varian Real-time Position Management (RPM) system', 'armGroupLabels': ['Breathe Well + RPM', 'RPM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}], 'overallOfficials': [{'name': 'Gillian Lamoury, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal North Shore Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sydney', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}