Photobiomodulation in Radiodermatitis in People With Breast Cancer

NCT ID: NCT06990165

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2029-04-30

Brief 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.

Detailed Description

This study is a Randomized Controlled Superiority Clinical Trial involving individuals diagnosed with breast cancer and indicated for adjuvant radiotherapy at Hospital do Câncer III of the National Cancer Institute (HCIII/INCA) in Rio de Janeiro. All individuals attending HCIII/INCA for their first consultation for adjuvant radiotherapy for breast cancer will be recruited to assess eligibility criteria for the study. Those deemed eligible will receive detailed explanations regarding the study objectives, treatment groups, adverse effects, and the voluntary nature of participation through the Informed Consent Form (ICF). Upon agreeing and signing the ICF, they will undergo an initial assessment and be randomized into one of the following groups: Active Photobiomodulation Group (intervention) or Placebo Photobiomodulation Group (control).

Randomization will follow a 1:1 allocation ratio between the two groups and will be conducted using sealed, opaque envelopes in blocks of ten patients, each containing an allocation code (five codes for Active Photobiomodulation Group and five codes for Placebo Photobiomodulation Group). This method was chosen to prevent biases related to therapist or participant preferences regarding the intervention. The participants will be informed about their assigned group and the follow-up procedures throughout radiotherapy and up to three months after treatment. All assessments, interventions, and data collection will be performed by trained and qualified professionals.

At the beginning of radiotherapy, all participants will receive guidance on skin care, specific home exercises for the upper limbs, and maintaining their usual physical activities, following the institutional standard of care.

Sociodemographic characteristics (age, race/skin color, education level, marital status, and per capita income) and clinical data (comorbidities, physical activity, tobacco and alcohol consumption, body mass index, physiotherapy follow-up, clinical staging, cancer treatment history, post-operative scar complications, and oncologic treatment-related complications) will be collected from physical and electronic medical records.

For data analysis, descriptive and comparative analyses will be performed between the intervention groups concerning selected variables and primary outcomes. Measures of central tendency and dispersion will be determined for continuous variables, and frequency distribution will be used for categorical variables. Outcome evaluations (primary and secondary) will follow an intention-to-treat analysis. The Kolmogorov-Smirnov test will be used to assess data normality. Chi-square tests will analyze categorical outcomes and will be presented in absolute and relative numbers. Student's t-tests will analyze parametric continuous outcomes and will be presented as mean and standard deviation, while the Mann-Whitney test will be used for non-parametric data, presented as median and minimum-maximum values. A significance level of p<0.05 and a 95% confidence interval will be considered for all analyses, which will be performed using SPSS (Statistical Package for the Social Sciences) version 24.

This research will not impose any financial burden on participants, as assessments will be conducted during routine consultations or treatment sessions, and additional data will be collected from electronic and/or physical medical records. The intervention materials (Antares photobiomodulation device by IBRAMED®, two protective glasses for the operator and patient, power cable, fuse, and operation manual) will be provided to the Clinical Epidemiology Applied to Oncology research group (on loan from IBRAMED® during the study period). Other office supply costs will be covered by the researchers responsible for the study.

Conditions

Breast Cancer; Radio Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

active photobiomodulation group (Group A)

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).

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: DEVICE

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.

placebo photobiomodulation group (Group B)

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.

Group Type: SHAM_COMPARATOR

Sham Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Low-Level Light Therapy; Photobiomodulation Therapy; Low-Level Laser Therapy; Low-Power Laser Irradiation; Laser Phototherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anke Bergmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anke Bergmann, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (INCA-BRAZIL)

Locations

National Cancer Institute (INCA-BRAZIL)

Rio de Janeiro, Rio de Janeiro, Brazil

National Cancer Institute / Cancer Hospital III - Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Central Contacts

Anke Bergmann, PhD

Role: CONTACT

abergmann@inca.gov.br

+55 21 32076551

Suzana S Aguiar

Role: CONTACT

saguiar@inca.gov.br

+552132076660

Facility Contacts

José Fontes Junior, bachelor

Role: primary

juniorfontes03@gmail.com

+552132076660

Other Identifiers

83380324.4.0000.5274

Identifier Type: -

Identifier Source: org_study_id