The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients (NCT05557825) | Clinical Trial Compass
CompletedNot Applicable
The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients
Brazil3 participantsStarted 2023-01-20
Plain-language 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 threee head and neck cancer patients with grade 2 to 4 followed up from 2022 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with diagnosis of head or neck cancer
* Must be undergoing Radiotherapy
* Must have a diagnosis of Grade II, III or IV radiodermatitis by RTOG Scale, made during the follow-up of the patient in their routine treatment at the hospital by the oncology team
* who do not present clinical signs of another pathology that justifies the presence of the dermis lesion.
Exclusion Criteria:
* Critical clinical states;
* End-of-life or palliative care;
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale)
Timeframe: Change from Baseline at 14 days after end of radiotherapy treatment