Clinical trial NCT05561803: The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.
Official title: The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Radiodermatitis; Acute
Radiotherapy Side Effect
Cancer Patients
Palliative Care
Keywords: Radiodermatitits
Radiotherapy
Photobiomodulation
Cancer
Palliative Care
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient cancer patients on palliative care undergoing radiotherapy and who show signs of radiodermatitis RTOG II OR III.

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Older than 18 years;
2. Patients with any oncological etiology;
3. With the presence of established radiodermatitis RTOG II or III;
4. Patients who are undergoing palliative oncological care and RD standard treatment;
5. Patients who do not present clinical signs of another pathology that justifies the presence of the skin lesion;
6. Patients do not have local skin infection

Exclusion Criteria:

* Critical clinical states;
* Patients with skin lesions of another cause even when undergoing RT;
* Patients referred to the laser clinic for the prevention of radiodermatitis without the active RD lesion.
* Patients who have used another photobiomodulation therapy protocol foresaw injury not related to the study.
* 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

Primary outcomes:
measure: Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale)
timeFrame: Change from Baseline at 14 days after end of radiotherapy treatment]
measure: Lesion Size
timeFrame: Change from Baseline at 14 days after end of radiotherapy treatment]
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]
Secondary outcomes:
measure: Visual Analog Scale of Pain
timeFrame: Change from Baseline at 14 days after end of radiotherapy treatment]
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
state: Sao Paulo
Study officials:
affiliation: University of Nove de Julho
name: Rebeca B Cecatto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: