Photobiomodulation in Radiodermatitis in People With Breast Cancer

NCT06990165 | Not Yet Recruiting

• 1 other identifier: 83380324.4.0000.5274
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Radio Dermatitis

Keywords

Physical Therapy; Phototherapy; Low-Level Light Therapy; Radiodermatitis; Adverse effects; Radiotherapy Adjuvant; Breast Neoplasms

Outcome Measures

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.

  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 (12)

• Incidence, intensity and modulation of pain assessed using the Visual Analog Scale (VAS) over 5 months after the start of adjuvant radiotherapy

  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.

• Characteristics and intensity of pain assessed by the Pain DETECT questionnaire over 5 months after the start of adjuvant radiotherapy

  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.

• Pain components assessed by the McGILL questionnaire over 5 months after the start of adjuvant radiotherapy

  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.

• Incidence and severity of edema/lymphedema over 5 months after the start of adjuvant radiotherapy.

  Assessments will be conducted at the baseline and end of radiotherapy treatment, as well as at 30 days and 3 months after its completion.

• Superficial sensitivity of the irradiated skin assessed by esthesiometry over 5 months after the start of adjuvant radiotherapy

  Assessments will be conducted at the baseline and end of radiotherapy treatment, as well as at 30 days and 3 months after its completion.

Study Arms (2)

active photobiomodulation group (Group A)

EXPERIMENTAL

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).

Device: Photobiomodulation

placebo photobiomodulation group (Group B)

SHAM COMPARATOR

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.

Other: Sham Control

Interventions

Photobiomodulation 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.

Also known as: Low-Level Light Therapy, Photobiomodulation Therapy, Low-Level Laser Therapy, Low-Power Laser Irradiation, Laser Phototherapy

active photobiomodulation group (Group A)

Sham Control 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.

placebo photobiomodulation group (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 years or older with an indication for adjuvant radiotherapy for breast cancer treatment at National Cancer Institute (INCA-BRAZIL).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (2)

National Cancer Institute (INCA-BRAZIL)

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

National Cancer Institute / Cancer Hospital III - Brazil

Rio de Janeiro, Rio de Janeiro, 20560-121, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Anke Bergmann, PhD

  National Cancer Institute (INCA-BRAZIL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke Bergmann, PhD

CONTACT

+55 21 32076551; abergmann@inca.gov.br

Suzana S Aguiar

CONTACT

+552132076660; saguiar@inca.gov.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 25, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)