Clinical trial · Interventional
Photobiomodulation in Radiodermatitis in People With Breast Cancer
Efficacy of Photobiomodulation in the Prevention and Severity of Radiodermatitis in People With Breast Cancer Undergoing Adjuvant Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Most breast cancer patients undergoing radiotherapy develop radiodermatitis, making it one of the most prevalent adverse events during cancer treatment. The severity of radiodermatitis can pose a life-threatening risk to patients, lead to functional limitations, delay treatment (pauses for tissue recovery), reduce the radiation dose, and negatively impact health-related quality of life. There is no consensus on the ideal strategy for preventing radiodermatitis. Photobiomodulation is a non-invasive strategythat may stimulate skin regeneration and minimize radiodermatitis without interfering with cancer treatment, with minimal risk (it may cause rare allergic-type complications or discomfort due to material contact) and low cost for both the patient and the healthcare system, making this approach highly relevant. Reducing the use of pharmaceuticals, the duration of radiotherapy treatment, and the costs associated with managing radiodermatitis will have socioeconomic and environmental impacts, as this is a sustainable, safe, and cost-effective therapeutic approach with high applicability and clinical reproducibility. Additionally, it can later be expanded to other types of cancer. This study hypothesizes that photobiomodulation can prevent and reduce complications associated with radiodermatitis in breast cancer patients undergoing adjuvant radiotherapy. Therefore, the primary objective of this clinical trial is to assess the efficacy of photobiomodulation in preventing and reducing the severity of radiodermatitis in breast cancer patients receiving adjuvant radiotherapy at Hospital do Câncer III of the Brazilian National Cancer Institute. The secondary objectives include evaluating the incidence and severity grades of radiodermatitis; comparing the influence of photobiomodulation, according to the intervention group, on the occurrence and severity of radiodermatitis, pain, edema/lymphedema, paresthesia, functionality, skin quality, health-related quality of life, and sleep quality after radiotherapy; comparing the recovery time of radiodermatitis between groups; and assessing satisfaction, safety, and tolerability of photobiomodulation use.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radio Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation | Device | — | UNRESOLVED |
| Sham Control | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- active photobiomodulation group (Group A)
- description
- Will receive photobiomodulation using the Antares/IBRAMED® device with a cluster applicator, at two distinct wavelengths: infrared laser light (808 nm) and red light (630 nm).
- interventionNames
- Device: Photobiomodulation
- type
- SHAM_COMPARATOR
- label
- placebo photobiomodulation group (Group B)
- description
- Group B will undergo the same protocol as Group A, with the device making contact with the irradiated area, but the device will be turned off, therefore not emitting any therapeutic light.
- interventionNames
- Other: Sham Control
Primary outcomes (1)
- measure
- Incidence and severity of radiodermatitis as assessed by the Radiation Therapy Oncology Group / European Organisation for Research and Treatment of Cancer (RTOG/EORTC) Classification System over 5 months after the start of adjuvant radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals aged 18 years or older with an indication for adjuvant radiotherapy for breast cancer treatment at National Cancer Institute (INCA-BRAZIL). Exclusion Criteria: * Previous diagnosis of cancer or bilateral breast cancer. * Oncological treatment outside the institution. * Connective tissue disorders (such as scleroderma and lupus erythematosus). * Previous radiotherapy to the breast or chest wall. * Individuals unable to complete the questionnaires. * Individuals unable to receive photobiomodulation due to acute infections.
References
Publications (0)
Data not yet available