Photobiomodulation in Radiodermatitis in People With Breast Cancer

Summary

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

• Breast Cancer
• Radio Dermatitis

Interventions

DEVICE

Photobiomodulation

Photobiomodulation applications will be performed within 1 hour after the radiotherapy session, covering the entire irradiated area, three times per week, starting from the first day of radiotherapy. The procedure will be conducted using the Antares/IBRAMED® device, with a cluster applicator featuring a 20 cm² contact area and two distinct wavelengths: four infrared laser diodes (808 nm), each with a power of 180 mW, and three red light diodes (630 nm), each with a power of 150 mW. Each diode will deliver 3 J of energy, with the wavelengths applied separately and sequentially.

OTHER

Sham Control

Group B will have the device in contact with the irradiated area, following the same protocol as Group A, but with the device turned off, receiving no therapeutic light and, therefore, experiencing no biological effects from the light.

Sponsors & Collaborators

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Instituto Nacional de Cancer, Brazil

  lead OTHER_GOV

Principal Investigators

• Anke Bergmann, PhD · National Cancer Institute (INCA-BRAZIL)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-31

Primary Completion

2026-07-31

Completion

2029-04-30

Countries

• Brazil

Study Locations