Photobiomodulation in Radiodermatitis in People With Breast Cancer
148 patients around the world
Available in Brazil
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.
Instituto Nacional de Cancer, Brazil
1Research sites
148Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Individuals aged 18 years or older with an indication for adjuvant radiotherapy for breast cancer treatment at National Cancer Institute (INCA-BRAZIL).
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.
Sites
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Pr. da Cruz Vermelha, 23 - Centro, Rio de Janeiro - RJ, 20230-130