This is a randomized, open-label, single-institution trial designed to evaluate the effectiveness of a spray skin protector in preventing moist desquamation caused by radiotherapy treatment. This technology, spray skin protection, depending on the manufacturer, is primarily intended to prevent or reduce contact dermatitis. However, this study will be evaluated for use in preventing moist desquamation caused by ionizing radiation. The comparing agent will be a moisturizer, agreed upon at the local Institution of the study for use in the prevention of radiodermatitis. As secondary objectives: describe adverse events, diarrhea, pain and pruritus. The study will be conducted at the radiotherapy outpatient clinic of the Cancer Hospital I (HCI) of National Cancer Institute (INCA) in Brazil.
The hypotheses are: Null (Ho): The incidence of moist desquamation with the spray skin protector is greater than or equal to the incidence of moist desquamation in the control group. Alternative (H1): The incidence of moist desquamation with the spray skin protector is lower than the incidence of moist desquamation in the control group. The evaluation of the skin of the participants will be weekly, with blinding of this professional. For the evaluation of secondary objectives, adverse events will be applied in the assessment scales of diarrhea, pruritus and pain by the CTCAE version 5.0; and the burning or burning sensation will be recorded only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
72
Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.
Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.
INCA Research Center
Rio de Janeiro, Rio de Janeiro, Brazil
Number of Participants Categorized by RTOG Grading Scale
RTOG ACUTE Radiation Morbidity - Tissue: Skin * Grade 1: Follicular, faint or dull erythema / epilation / dry desquamation / decreased sweating; * Grade 2: Tender or bright erythema, patchy moist desquamation / moderate edema; * Grade 3: Confluent, moist desquamation other than skin folds, pitting edema; * Grade 4: Ulceration, hemorrhage, necrosis.
Time frame: From the first day of radiotherapy up to eight weeks
Adverse Events
Occurrence of adverse events after the beginning of radiotherapy
Time frame: From the first day of radiotherapy up to eight weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.