Clinical trial NCT06990165: Photobiomodulation in Radiodermatitis in People With Breast Cancer
Official title: Efficacy of Photobiomodulation in the Prevention and Severity of Radiodermatitis in People With Breast Cancer Undergoing Adjuvant Radiotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Radio Dermatitis
Keywords: Physical Therapy
Phototherapy
Low-Level Light Therapy
Radiodermatitis
Adverse effects
Radiotherapy Adjuvant
Breast Neoplasms
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Cnpq Conselho Nacional de Desenvolvimento Científico e Tecnológico National Counsel of Technological and Scientific Development
First posted: 2025-05-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be by lot when the patient enters the study. Envelopes will be made available that will contain a code that determines the allocation of patients in the intervention group experimental or standard.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
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.
timeFrame: Evaluations will be performed in baseline, once a week during treatment (which lasts an average of 5 weeks), as well as at 30 days and 3 months after the end of radiotherapy.
Secondary outcomes:
measure: Incidence, intensity and modulation of pain assessed using the Visual Analog Scale (VAS) over 5 months after the start of adjuvant radiotherapy
timeFrame: Evaluations will be performed in baseline and each photobiomodulation intervention (which lasts an average of 5 weeks), as well as at 30 days and 3 months after the end of radiotherapy.
measure: Characteristics and intensity of pain assessed by the Pain DETECT questionnaire over 5 months after the start of adjuvant radiotherapy
timeFrame: Evaluations will be performed in baseline once a week during treatment (which lasts an average of 5 weeks), as well as at 30 days and 3 months after the end of radiotherapy.
measure: Pain components assessed by the McGILL questionnaire over 5 months after the start of adjuvant radiotherapy
timeFrame: Evaluations will be performed in baseline, once a week during treatment (which lasts an average of 5 weeks), as well as at 30 days and 3 months after the end of radiotherapy.
measure: Incidence and severity of edema/lymphedema over 5 months after the start of adjuvant radiotherapy.
timeFrame: Assessments will be conducted at the baseline and end of radiotherapy treatment, as well as at 30 days and 3 months after its completion.
measure: Superficial sensitivity of the irradiated skin assessed by esthesiometry over 5 months after the start of adjuvant radiotherapy
timeFrame: Assessments will be conducted at the baseline and end of radiotherapy treatment, as well as at 30 days and 3 months after its completion.
measure: Functionality of the upper limb on the irradiated side assessed by the Disability of Arm, Shoulder, and Hand (DASH) Questionnaire over 5 months after the start of adjuvant radiotherapy.
timeFrame: Evaluations will be performed in baseline , 30 days and 3 months after the end of radiotherapy.
measure: Skin quality over 5 months after the start of adjuvant radiotherapy, analyzed by thermography
timeFrame: The assessment will begin one week after the first radiotherapy session and will be repeated once a week during the treatment (which lasts on average 5 weeks), as well as 30 days and 3 months after the end of radiotherapy.
measure: Health-Related Quality of Life assessed by the EORTC QLQ-C30 (3rd version) and EORTC QLQ-BR23 questionnaires over 5 months after the start of adjuvant radiotherapy.
timeFrame: Assessments will be conducted at the baseline and end of radiotherapy, as well as at 30 days and 3 months after its completion
measure: Sleep quality according to the Pittsburgh Sleep Quality Index (PSQI) over 5 months after the start of adjuvant radiotherapy
timeFrame: Assessments will be conducted at the baseline and end of radiotherapy, as well as at 30 days and 3 months after its completion
measure: Satisfaction and impact of photobiomodulation on participants' health condition at the end of radiotherapy
timeFrame: Approximately 5 weeks from the start of radiotherapy (21 days)
measure: Safety and tolerability to photobiomodulation
timeFrame: The assessment will begin one week after the first radiotherapy session and will be repeated once a week during the treatment (which lasts on average 5 weeks), as well as 30 days and 3 months after the end of radiotherapy.
measure: Interruption of radiotherapy
timeFrame: Throughout radiotherapy
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Cancer Institute (INCA-BRAZIL)
state: RJ
city: Rio de Janeiro
country: Brazil
facility: National Cancer Institute / Cancer Hospital III - Brazil
Study officials:
affiliation: National Cancer Institute (INCA-BRAZIL)
name: Anke Bergmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: