Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiodermatitis
- Sponsor
- Instituto Nacional de Cancer, Brazil
- Enrollment
- 148
- Primary Endpoint
- Degree of Radiodermatitis
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Rejane Medeiros Costa
Physiotherapist
Instituto Nacional de Cancer, Brazil
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Degree of Radiodermatitis
Time Frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Objective scoring of the severity of radiodermatitis using the classification system of the Radiotherapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG / EORTC), where the set of skin reactions caused by radiotherapy is classified as grade 0: when there is no reaction; grade 1: mild erythema, epilation and dry flaking; grade 2: painful erythema, moist flaking, and moderate edema; grade 3: wet flaking, confluent and important edema; ulceration, bleeding and necrosis.
Secondary Outcomes
- Pain at the application site(one day, 30 days, 3 and 6 months after radiotherapy treatment)
- Paresthesia(one day, 30 days, 3 and 6 months after radiotherapy treatment)
- Edema/Lymphedema(one day, 30 days, 3 and 6 months after radiotherapy treatment)
- Functionality(one day, 30 days, 3 and 6 months after radiotherapy treatment)
- Skin quality(one day, 30 days, 3 and 6 months after radiotherapy treatment)
- Questionnaire about Health-related quality of life(one day, 30 days, 3 and 6 months after radiotherapy treatment)
- Questionnaire about Satisfaction with photobiomodulation(one day, 30 days, 3 and 6 months after radiotherapy treatment)
- Questionnaire about Impact of radiodermatitis(one day, 30 days, 3 and 6 months after radiotherapy treatment)