Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-28 @ 6:02 AM
Study NCT ID:
NCT05561803
Status:
WITHDRAWN
Last Update Posted:
2024-03-12
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011855', 'term': 'Radiodermatitis'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Research team withdrawn the study before starting the recruitment because the university suspended the service for administrative restructuring', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-04-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-09', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale)', 'timeFrame': 'Change from Baseline at 14 days after end of radiotherapy treatment]', 'description': 'RTOG scale assess the degree and intensity of RD. It identifies degree 0 (no reaction), 1 (faint erythema, dry desquamation, epilation, diminished sweating), 2 (moderate, brisk erythema, exudative dermatitis in plaques and moderate edema), 3 (exudative dermatitis, besides cutaneous folds and intense edema) and 4 (ulceration, hemorrhage, necrosis).'}, {'measure': 'Lesion Size', 'timeFrame': 'Change from Baseline at 14 days after end of radiotherapy treatment]', 'description': 'Evaluation of lesion measurement in centimeters'}, {'measure': 'Portuguese version of The World Health Organization Quality of Life Scale (WHOQOL-BREF)', 'timeFrame': 'Change from Baseline at 14 days after end of radiotherapy treatment]', 'description': 'The WHOWOL BREF scale assess multidimensional aspects of geral quality of life of patients. The multidimensional scale is composed by 26 items, classified from 1 to 5 according to the intensity of the symptom presented. The global score is calculated by adding up all the items as well as the score for each domain is evaluated adding it individually for each item, which can range from 0 to 130,'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale of Pain', 'timeFrame': 'Change from Baseline at 14 days after end of radiotherapy treatment]', 'description': "VAS Scale assess the pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiodermatitits', 'Radiotherapy', 'Photobiomodulation', 'Cancer', 'Palliative Care'], 'conditions': ['Radiodermatitis; Acute', 'Radiotherapy Side Effect', 'Cancer Patients', 'Palliative Care']}, 'descriptionModule': {'briefSummary': "It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis on Palliative Care, treated with PBM. This is a case series report and the study data will be extracted from the medical records of forty cancer patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.", 'detailedDescription': "It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of forty cancer patients on palliative care diagnosed with radiotherapy-induced acute radiodermatitis Grade 2or 3, treated with PBM. This is a case series report and the study data will be extracted from the medical records of patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The assessment will be done pre-treatment, weekly during PBM therapy and post-treatment. The PBM therapy are focal low-level laser therapy, 1 to 3 Joules per point, depending on the degree of pain, wavelength 633 to 685 nm, transcutaneously on the surface of the tissue injured by radiotherapy, three times a week during radiotherapy treatment and two more applications after the end of radiotherapy The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatient cancer patients on palliative care undergoing radiotherapy and who show signs of radiodermatitis RTOG II OR III.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Older than 18 years;\n2. Patients with any oncological etiology;\n3. With the presence of established radiodermatitis RTOG II or III;\n4. Patients who are undergoing palliative oncological care and RD standard treatment;\n5. Patients who do not present clinical signs of another pathology that justifies the presence of the skin lesion;\n6. Patients do not have local skin infection\n\nExclusion Criteria:\n\n* Critical clinical states;\n* Patients with skin lesions of another cause even when undergoing RT;\n* Patients referred to the laser clinic for the prevention of radiodermatitis without the active RD lesion.\n* Patients who have used another photobiomodulation therapy protocol foresaw injury not related to the study.\n* All contraindications already defined in the routine referral to the outpatient clinic (patients who have an active tumor at the site to be irradiated; individuals with a history of photosensitivity to photonic or light therapy; patients who have undiagnosed lesions in the treatment region; patients using topical photosensitizing medications or creams; cognitive, psychiatric or neurological changes that prevent the free understanding of the PBM therapy'}, 'identificationModule': {'nctId': 'NCT05561803', 'briefTitle': 'The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.', 'orgStudyIdInfo': {'id': 'Radiodermatitistalita30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiodermatitis Case Group', 'description': '40 patients on palliative care with grade 2 or grade 3 radiodermatitis after radiotherapy for the treatment of cancer submitted to a PBM therapy protocol', 'interventionNames': ['Radiation: Photobiomodulation Therapy']}], 'interventions': [{'name': 'Photobiomodulation Therapy', 'type': 'RADIATION', 'otherNames': ['PBM Therapy'], 'description': 'Focal low-level laser therapy, Red Laser (wavelength 633 nm to 685 nm), or Infrared Laser Laser (wavelength 780 nm to 830 nm), with a low-intensity laser equipment of 100 mW and a cross-sectional area of the device beam of 0.0434 cm². The parameters are 1 to 3 J per point, with equidistant points of 1.5 to 2 cm, covering the entire length of the open lesion. Therapy is carried out every 48 hours until the total wound healing, regardless of the number of sessions required.', 'armGroupLabels': ['Radiodermatitis Case Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Rebeca B Cecatto, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Rebeca Boltes Cecatto', 'investigatorFullName': 'Rebeca Boltes Cecatto', 'investigatorAffiliation': 'University of Nove de Julho'}}}}