Photobiomodulation in Radiodermatitis in People With Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Cancer, Brazil
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18 years or older with an indication for adjuvant radiotherapy for breast cancer treatment at National Cancer Institute (INCA-BRAZIL).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation
DevicePhotobiomodulation 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.
Sham Control
Other interventionGroup 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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: active photobiomodulation group (Group A)Experimental treatment 1 intervention
Group B: placebo photobiomodulation group (Group B)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
The set of skin reactions caused by radiotherapy treatment is classified by the Radiation Therapy Oncology Group / European Organisation for Research and Treatment of Cancer (RTOG/EORTC) system as follows: Grade 0 - no reaction; Grade 1 - mild erythema, epilation, and dry desquamation; Grade 2 - painful erythema, moist desquamation, and moderate edema; Grade 3 - confluent moist desquamation and significant edema; Grade 4 - ulceration, hemorrhage, and necrosis.
Time frame
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
1
Incidence, intensity and modulation of pain assessed using the Visual Analog Scale (VAS) over 5 months after the start of adjuvant radiotherapy
Pain incidence, intensity and modulation will be assessed using the Visual Analog Scale (VAS) at each intervention. This is a Likert-type scale ranging from 0 (no pain) to 10 (unbearable pain).The VAS will be applied to each intervention, as well as at 30 days and 3 months after the end of radiotherapy.
Time frame
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.2
Characteristics and intensity of pain assessed by the Pain DETECT questionnaire over 5 months after the start of adjuvant radiotherapy
The Pain DETECT questionnaire is an instrument that characterizes the type of pain based on a score, which ranges from 1 to 38 points (≤ 12 points indicates an unlikely neuropathic component, with nociceptive pain; between 13 and 18 points, indicates mixed pain; and scores ≥ 19 points suggest a probable neuropathic component and neuropathic pain).
Time frame
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.3
Pain components assessed by the McGILL questionnaire over 5 months after the start of adjuvant radiotherapy
The McGILL questionnaire is an instrument that characterizes the pain components as affective, sensory, and evaluativeproviding qualitative information through patient descriptions. The McGILL questionnair will be administered once per week during treatment, as well as at 30 days and 3 months after the end of radiotherapy.
Time frame
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.4
Incidence and severity of edema/lymphedema over 5 months after the start of adjuvant radiotherapy.
Assessments will be conducted at the beginning and end of radiotherapy, as well as at 30 days and 3 months after its completion, using upper limb perimetry. Measurement points will include: (1) elbow joint line (EJL); (2) 7 cm and 14 cm above the EJL; (3) 7 cm, 14 cm, and 21 cm below the EJL; and (4) the dorsum of the hand. The total limb volume will be calculated using the truncated cone formula based on circumference measurements: V = h \* (C² + Cc + c²) / (π \* 12), where 'V' represents the total segment volume of the limb, 'C' and 'c' are the circumferences at the measured points, and 'h' is the distance between the circumferences in each segment. Lymphedema will be defined as a total volume difference of ≥ 10% between the affected and contralateral limb after six months of surgical treatment. Edema will be defined as a total volume difference of ≥ 10% within the first six months after surgery.
Time frame
Assessments will be conducted at the baseline and end of radiotherapy treatment, as well as at 30 days and 3 months after its completion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Instituto Nacional de Cancer, Brazil
Lead sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Source ClinicalTrials.gov
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