The Use of Photobiomodulation in the Management of Radiodermatitis in Breast Cancer Patients
Study Details
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 Breast Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis treated with PBM. This is a case series report and the study data will be extracted from the medical records of sixty breast cancer patients with grade 2 or 3 RD followed up from September 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 therapy. The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 sixty breast cancer patients 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 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 therapy. The assessment will be done pre-treatment, weekly during PBM therapy and post-treatment. The PBM therapy are focal low-level laser therapy, 2 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Radiodermatitis Case Group 60 patients with grade 2 or grade 3 radiodermatitis after radiotherapy for the treatment of breast cancer submitted to a PBM therapy protocol |
Radiation: Photobiomodulation Therapy
Focal low-level laser therapy, 2 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale) [Change from Baseline at 14 days after end of radiotherapy treatment]]
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).
- Lesion Size [Change from Baseline at 14 days after end of radiotherapy treatment]]
Evaluation of lesion measurement in centimeters
Secondary Outcome Measures
- Visual Analog Scale of Pain [Change from Baseline at 14 days after end of radiotherapy treatment]]
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').
Other Outcome Measures
- Complete blood count (CBC) [Change from Baseline at 14 days after end of radiotherapy treatment]]
A complete blood count test measures components and features of blood, including: red blood cells, white blood cells, hemoglobin, Hematocrit, Platelets.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with diagnosis of breast cancer
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Must be undergoing Radiotherapy
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Must have a diagnosis of Grade II and/or III radiodermatitis by RTOG Scale, made during the follow-up of the patient in their routine treatment at the hospital by the oncology team
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who do not present clinical signs of another pathology that justifies the presence of the dermis lesion.
Exclusion Criteria:
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Critical clinical states;
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End-of-life or palliative care;
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Patients with skin lesions of another cause even when undergoing RT;
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Patients referred to the laser clinic for the prevention of radiodermatitis without the active RD lesion.
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Patients who have used another photobiomodulation therapy protocol foresaw injury not related to the study.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences | São Paulo | Sao Paulo | Brazil |
Sponsors and Collaborators
- University of Nove de Julho
Investigators
- Principal Investigator: Rebeca B Cecatto, Ph.D., University of Nove de Julho
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Radiodermatitistalita60