Radiodermatitis
Conditions
Interventions
This is a randomized controlled clinical trial, which will be carried out with 90 women with breast cancer undergoing radiotherapy, from May 2022 to July 2023, of which 45 women will be randomly alloc
E02.594.540
Sponsors
Universidade de São Paulo
Hospital São Domingos
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women over eighteen years of age; diagnosed with breast cancer; who may have undergone surgical treatment, whether radical or conservative; with indication of starting adjuvant or neoadjuvant radiotherapy will be included.
Exclusion criteria
Exclusion criteria: Pregnant patients who underwent previous irradiation of the area; who are undergoing concomitant chemotherapy; who present postoperative complications such as dehiscence of the surgical wound or presence of seroma; women with malignant neoplastic wound or with the presence of dermatoses in the area to be be irradiated; women who miss treatment on the proposed day; who have been hospitalized due to an oncological emergency or who died during the course of the research; women who present grade III or IV radiodermatitis after the beginning of the radiotherapy sessions who need to interrupt the treatment until the lesion improves.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will correspond to the incidence of acute radiodermatitis, as well as its graduation and the time for its manifestation between the groups, which will be evaluated by the Radiation Therapy Oncology Group (RTOG) scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes will be the quality of life of these women, the symptoms reported by the patients and the temperature variation of the irradiated breast during the treatment, which will be evaluated, respectively, by the Cancer Quality of Life Questionnaire-30 (EORTC QLQ- 30), Quality of Life Questionnaire - Breast Cancer Module (EORTC-QLQ-BR23) and the analysis of thermal images of the irradiated area. | — |
Countries
Brazil
Contacts
Public ContactSuzy Rocha
Universidade de São Paulo
Outcome results
None listed