Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-03 @ 9:48 AM
Study NCT ID:
NCT01925651
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2013-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011855', 'term': 'Radiodermatitis'}], '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': 'D003872', 'term': 'Dermatitis'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Local Care Costs', 'timeFrame': 'participants will be followed for the duration of radiotherapy, an expected average of 6 weeks', 'description': 'Local Care Costs with radiodermatitis'}, {'measure': 'Local Control', 'timeFrame': 'From date of randomization until the date of first documented local progression in the chest wall or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'local control in the chest wall assessed by physical examination and complementary exams.'}, {'measure': 'Metastasis-Free Interval', 'timeFrame': 'From date of randomization until the date of first documented distant progression or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'Metastasis-Free Interval (following departmental post-treatment surveillance visits routine).'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'Overall Survival (following departmental post-treatment surveillance visits routine).'}], 'primaryOutcomes': [{'measure': 'Acute radiodermatitis', 'timeFrame': 'participants will be followed for the duration of radiotherapy, an expected average of 6 weeks', 'description': 'Radiation Therapy Oncology Group (RTOG) grading system Common Terminology Criteria for Adverse Events (CTCAE) - v4.0'}], 'secondaryOutcomes': [{'measure': 'Interruption Time', 'timeFrame': 'participants will be followed for the duration of radiotherapy, an expected average of 6 weeks', 'description': 'Treatment Interruption time due to radiodermatitis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post Mastectomy Radiotherapy', 'Breast Cancer', 'Bolus', 'Radiodermatitis'], 'conditions': ['Breast Cancer', 'Radiodermatitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy after mastectomy, in relation to the time of treatment interruption and acute effects. This study evaluates whether there is an increase in treatment time with the addition of the bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous tissue. The patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.', 'detailedDescription': 'Rational:\n\n* The use of high-energy photons (6 MeV) creates a characteristic skin-sparing effect, which can generate a region of low-dose subcutaneous tissue.\n* The subcutaneous tissue is a possible area of clinical failure in the chest wall after mastectomy for breast cancer.\n* To optimize treatment, it is used a bio-equivalent material to increase the surface dose.\n* This dose increase may be accompanied by greater skin reaction, making it necessary to temporarily discontinue treatment to recover radiodermatitis.\n* The total treatment time is a determinant of tumor control in the treatment of cancer with radiation.\n\nDescription:\n\n* This study aims to evaluate whether different intensities of application of the bolus correlate with greater likelihood of treatment discontinuation.\n* This will be a single blind randomised controlled trial. The target population comprises patients with indication of post mastectomy radiation (PMRT).\n* The patients will be divided into two groups: one with higher risk of recurrence in subcutaneous, which will be randomized to use 0.5cm bolus every other day or on consecutive days, and one lower risk group, which will be randomized to use bolus 0.5cm on alternate days or do not use bolus. The group with high risk is defined as patients with clinical or pathological tumor invasion of skin. The others will be considered standard risk.\n* Randomization will be made so that each group has the same proportion of patients with high body mass index (\\> / = 30 kg/m2), as this may be a factor in worsening radiodermatitis.\n* The patients will be followed during treatment and will be evaluated weekly for the radiodermatitis, interruption time of treatment for recovery from the acute effects and expenditures for local care. The evaluation will be done blindly (without knowledge of the utilization of bolus) by trained nurses in the management of radiodermatitis. After treatment, patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing mastectomy with or without reconstruction of early breast\n* breast malignancy histologically proven\n* protocol addended to allow inclusion of men that meet all inclusion criteria\n\nExclusion Criteria:\n\n* Karnofsky Performance Scale (KPS) \\<70%\n* Concomitant chemotherapy (only permitted or hormone therapy molecular-targeted)\n* Prior ipsilateral thoracic / cervical irradiation\n* Proven metastatic disease (excluded from oncologic outcomes analyses)'}, 'identificationModule': {'nctId': 'NCT01925651', 'briefTitle': 'Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'AC Camargo Cancer Center'}, 'officialTitle': 'Randomized Clinical Trial of the Impact of the Use of Bolus in the Treatment of Post Mastectomy Radiotherapy for Breast Cancer', 'orgStudyIdInfo': {'id': 'AC-B 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Risk - No bolus', 'description': 'No Bolus', 'interventionNames': ['Radiation: No Bolus']}, {'type': 'OTHER', 'label': 'Standard Risk - Alternate Bolus', 'description': 'Alternate 5mm Bolus', 'interventionNames': ['Radiation: Alternate Bolus']}, {'type': 'OTHER', 'label': 'High Risk - Alternate Bolus', 'description': 'Alternate 5mm Bolus', 'interventionNames': ['Radiation: Alternate Bolus']}, {'type': 'OTHER', 'label': 'High Risk - Continuous bolus', 'description': 'Continuous 5mm bolus', 'interventionNames': ['Radiation: Continuous Bolus']}], 'interventions': [{'name': 'No Bolus', 'type': 'RADIATION', 'description': 'no bolus use', 'armGroupLabels': ['Standard Risk - No bolus']}, {'name': 'Alternate Bolus', 'type': 'RADIATION', 'description': '0.5cm bolus use in alternate days', 'armGroupLabels': ['High Risk - Alternate Bolus', 'Standard Risk - Alternate Bolus']}, {'name': 'Continuous Bolus', 'type': 'RADIATION', 'description': '0.5 cm bolus use in continuous days', 'armGroupLabels': ['High Risk - Continuous bolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01509-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'AC Camargo Cancer Center', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Lucas G Sapienza, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AC Camargo Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AC Camargo Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Lucas Gomes Sapienza', 'investigatorAffiliation': 'AC Camargo Cancer Center'}}}}