Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-02 @ 7:08 PM
Study NCT ID:
NCT02443493
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2015-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Dermatitis Grade', 'timeFrame': 'day 1', 'description': 'objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)'}, {'measure': 'Radiation Dermatitis Grade', 'timeFrame': 'day 20', 'description': 'objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)'}, {'measure': 'Radiation Dermatitis Grade', 'timeFrame': 'day 33', 'description': 'objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)'}, {'measure': 'Radiation Dermatitis Grade', 'timeFrame': 'day 40', 'description': 'objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)'}, {'measure': 'Radiation Dermatitis Grade', 'timeFrame': 'day 54', 'description': 'objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)'}, {'measure': 'Radiation Dermatitis Assessment', 'timeFrame': 'day 1', 'description': 'radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)'}, {'measure': 'Radiation Dermatitis Assessment', 'timeFrame': 'day 20', 'description': 'radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)'}, {'measure': 'Radiation Dermatitis Assessment', 'timeFrame': 'day 33', 'description': 'radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)'}, {'measure': 'Radiation Dermatitis Assessment', 'timeFrame': 'day 40', 'description': 'radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)'}, {'measure': 'Radiation Dermatitis Assessment', 'timeFrame': 'day 54', 'description': 'radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)'}, {'measure': 'Objective measurement of trans epidermal water loss of the skin', 'timeFrame': 'day 1', 'description': 'Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin'}, {'measure': 'Objective measurement of trans epidermal water loss of the skin', 'timeFrame': 'day 20', 'description': 'Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin'}, {'measure': 'Objective measurement of trans epidermal water loss of the skin', 'timeFrame': 'day 33', 'description': 'Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin'}, {'measure': 'Objective measurement of trans epidermal water loss of the skin', 'timeFrame': 'day 40', 'description': 'Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin'}, {'measure': 'Objective measurement of trans epidermal water loss of the skin', 'timeFrame': 'day 54', 'description': 'Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin'}, {'measure': 'Objective measurement of the skin hydration', 'timeFrame': 'day 1', 'description': 'Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration'}, {'measure': 'Objective measurement of the skin hydration', 'timeFrame': 'day 20', 'description': 'Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration'}, {'measure': 'Objective measurement of the skin hydration', 'timeFrame': 'day 33', 'description': 'Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration'}, {'measure': 'Objective measurement of the skin hydration', 'timeFrame': 'day 40', 'description': 'Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration'}, {'measure': 'Objective measurement of trans epidermal water loss of the skin', 'timeFrame': 'day 54', 'description': 'Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration'}, {'measure': 'Objective measurement of degree of erythema of the skin', 'timeFrame': 'day 1', 'description': 'Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin'}, {'measure': 'Objective measurement of degree of erythema of the skin', 'timeFrame': 'day 20', 'description': 'Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin'}, {'measure': 'Objective measurement of degree of erythema of the skin', 'timeFrame': 'day 33', 'description': 'Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin'}, {'measure': 'Objective measurement of degree of erythema of the skin', 'timeFrame': 'day 40', 'description': 'Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin'}, {'measure': 'Objective measurement of degree of erythema of the skin', 'timeFrame': 'day 54', 'description': 'Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin'}, {'measure': 'Analyze the skin cytokine content of the irradiated and non-irradiated breast', 'timeFrame': 'day 1', 'description': 'Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA'}, {'measure': 'Analyze the skin cytokine content of the irradiated and non-irradiated breast', 'timeFrame': 'day 20', 'description': 'Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA'}, {'measure': 'Analyze the skin cytokine content of the irradiated and non-irradiated breast', 'timeFrame': 'day 33', 'description': 'Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA'}, {'measure': 'Analyze the skin cytokine content of the irradiated and non-irradiated breast', 'timeFrame': 'day 40', 'description': 'Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA'}, {'measure': 'Analyze the skin cytokine content of the irradiated and non-irradiated breast', 'timeFrame': 'day 54', 'description': 'Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'day 1', 'description': 'Evaluation of pain using a Visual Analogue Scale (VAS)'}, {'measure': 'Pain', 'timeFrame': 'day 20', 'description': 'Evaluation of pain using a Visual Analogue Scale (VAS)'}, {'measure': 'Pain', 'timeFrame': 'day 33', 'description': 'Evaluation of pain using a Visual Analogue Scale (VAS)'}, {'measure': 'Pain', 'timeFrame': 'day 40', 'description': 'Evaluation of pain using a Visual Analogue Scale (VAS)'}, {'measure': 'Pain', 'timeFrame': 'day 54', 'description': 'Evaluation of pain using a Visual Analogue Scale (VAS)'}, {'measure': 'Quality of life', 'timeFrame': 'day 1', 'description': 'Health-related quality of life measure specific to skin diseases'}, {'measure': 'Quality of life', 'timeFrame': 'day 20', 'description': 'Health-related quality of life measure specific to skin diseases'}, {'measure': 'Quality of life', 'timeFrame': 'day 33', 'description': 'Health-related quality of life measure specific to skin diseases'}, {'measure': 'Quality of life', 'timeFrame': 'day 40', 'description': 'Health-related quality of life measure specific to skin diseases'}, {'measure': 'Quality of life', 'timeFrame': 'day 54', 'description': 'Health-related quality of life measure specific to skin diseases'}, {'measure': 'Satisfaction with therapy', 'timeFrame': 'day 1', 'description': 'Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis'}, {'measure': 'Satisfaction with therapy', 'timeFrame': 'day 20', 'description': 'Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis'}, {'measure': 'Satisfaction with therapy', 'timeFrame': 'day 33', 'description': 'Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis'}, {'measure': 'Satisfaction with therapy', 'timeFrame': 'day 40', 'description': 'Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis'}, {'measure': 'Satisfaction with therapy', 'timeFrame': 'day 54', 'description': 'Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis'}, {'measure': 'moist desquamation', 'timeFrame': 'day 1', 'description': '3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation'}, {'measure': 'moist desquamation', 'timeFrame': 'day 20', 'description': '3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation'}, {'measure': 'moist desquamation', 'timeFrame': 'day 33', 'description': '3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation'}, {'measure': 'moist desquamation', 'timeFrame': 'day 40', 'description': '3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation'}, {'measure': 'moist desquamation', 'timeFrame': 'day 54', 'description': '3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).\n\nCurrently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma\n* Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy\n* Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous irradiation to the same breast\n* Metastatic disease\n* Concurrent chemotherapy\n* Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)'}, 'identificationModule': {'nctId': 'NCT02443493', 'acronym': 'TRANSDERMIS', 'briefTitle': 'Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '15.38/onco15.06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)', 'interventionNames': ['Device: Low-level laser', 'Radiation: radiotherapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)', 'interventionNames': ['Device: sham laser', 'Radiation: radiotherapy']}], 'interventions': [{'name': 'Low-level laser', 'type': 'DEVICE', 'otherNames': ['LLLT'], 'description': 'Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.', 'armGroupLabels': ['Treatment group']}, {'name': 'sham laser', 'type': 'DEVICE', 'description': 'Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.', 'armGroupLabels': ['Control group']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ['Control group', 'Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Hospital - Oncology department', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Jeroen Mebis, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Hasselt/ Jessa ziekenhuis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'Prof. dr. Jeroen Mebis', 'investigatorAffiliation': 'Hasselt University'}}}}