Clinical trial · Observational
The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Research team withdrawn the study before starting the recruitment because the university suspended the service for administrative restructuring
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
| Radiodermatitis; Acute | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (3)
- 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]
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
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