Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy

Instituto Nacional de Cancer, Brazil

Status: Not yet enrolling

Conditions: Radiodermatitis

Treatments: Device: Photobiomodulation through LED board

Study type: Interventional

Funder types: Other

Identifiers

NCT05535452

Prevention of radiodermatitis

Details and patient eligibility

About

This is a Randomized Controlled Clinical Trial Women with breast cancer who are indicated for treatment with adjuvant radiotherapy will be eligible. Patients who underwent surgery and/or chemotherapy outside the institution and patients with comprehension difficulties will be excluded. After recruitment, women will be allocated into two groups: intervention (use of LED board) and control (placebo board). The degree of radiodermatitis, pain, edema and/or lymphedema, paresthesia, functionality, quality of life, skin conditions and related independent variables, such as the characteristics of the patient, the tumor and the oncological treatment performed will be evaluated. Thus, the hypothesis of the study is the prevention of radiodermatitis, which is a complication of radiotherapy treatment using photobiomodulation with LED board as a means of intervention.

Full description

Introduction: For Brazil, the INCA estimate is 66,280 new cases of breast cancer for each year of the 2020-2022 triennium. The treatment of breast cancer depends on the stage of the disease and the type of tumor. Treatment modalities are divided into systemic (chemotherapy, hormone therapy and biological therapy) and local (radiotherapy and surgery) that can be performed alone or in combination, according to clinical and tumor characteristics. Radiotherapy is associated with some adverse effects, including radiodermatitis, which is characterized by tissue damage that occurs immediately after the first radiotherapy session and, as subsequent sessions occur, resulting from dose fractionation, it starts to the dose accumulates in the skin, which causes the recruitment of inflammatory cells and the worsening of this complication. General objective: To evaluate the effectiveness of photobiomodulation with the application of the LED board in the prevention of radiodermatitis in women with breast cancer undergoing adjuvant radiotherapy at the Cancer Hospital III of the National Cancer Institute (HCIII/INCA). Materials and methods: This is a Randomized Controlled Clinical Trial Women with breast cancer who are indicated for treatment with adjuvant radiotherapy will be eligible. Patients who underwent surgery and/or chemotherapy outside the institution and patients with comprehension difficulties will be excluded. After recruitment, women will be allocated into two groups: intervention (use of LED board) and control (placebo board). The degree of radiodermatitis, pain, edema and/or lymphedema, paresthesia, functionality, quality of life, skin conditions and related independent variables, such as the characteristics of the patient, the tumor and the oncological treatment performed will be evaluated.

Enrollment: 148 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women over 18 years of age
• Stage I to IIIC breast cancer
• Have an indication for adjuvant radiotherapy treatment at HCIII/INCA.

Exclusion criteria

• have a previous diagnosis of cancer
• underwent surgery and/or chemotherapy outside the Institution
• were unable to respond to the questionnaires
• were unable to receive photobiomodulation due to acute infections will be excluded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

148 participants in 2 patient groups, including a placebo group

Group control

Placebo Comparator group

Description:

Patients will receive applications with the LED board turned off without light activation. Applications will be performed within 1 hour after radiotherapy, three times a week, by a trained team, consisting of physical therapists and physical therapy students, and the application time will be the same as in the intervention group. Women will be instructed to maintain specific home exercises for the upper limbs, which are part of the routine of the physiotherapy sector since the first postoperative day at the HCIII/INCA, in addition to their usual physical activities.

Treatment:

Device: Photobiomodulation through LED board

Intervention group

Experimental group

Description:

At the beginning of radiotherapy treatment, all HCIII/INCA patients are instructed by the nursing team in this sector to use the DNA® ointment provided at the institution and to take proper skin care. Patients identified by the nursing staff with some degree of radiodermatitis undergo treatment with silver sulfadiazine and, if necessary, radiotherapy can be interrupted so that the skin regenerates.

Treatment:

Device: Photobiomodulation through LED board