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Spots Global Cancer Trial Database for The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients

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Trial Identification

Brief Title: The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients

Official Title: The Use of Photobiomodulation in the Management of Radiotherapy Side Effects: Case Series of Head and Neck Cancer Patients

Study ID: NCT05557825

Study Description

Brief Summary: 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 Head and Neck Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis treated with PBM and/or PDT. This is a case series report and the study data will be extracted from the medical records of four head and neck cancer patients with grade 2 to 4 followed up from 2021 at the Laser Therapy Outpatient Clinic in a Universitarian Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS) and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM/PDT therapy. Data with positive or negative results will be reported.

Detailed Description: 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 Head and Neck Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis Grade 2 to 4, treated with PBM/PDT. This is a case series report and the study data will be extracted from the medical records of four head and neck cancer patients with grade 2 to 4 RD followed up from 2021 at the Laser Therapy Outpatient Clinic in a Universitarian Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS) and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM/PDT 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 630 to 830 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 Data with positive or negative results will be reported.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences, Sao Paulo, , Brazil

Contact Details

Name: Rebeca B Cecatto, M.D. Ph.D.

Affiliation: University of Nove de Julho

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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