Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized, Open-label Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis in Patients With Anal and Rectal Canal Cancer.

Conditions
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Radiodermatitis, Injury, Radiation

Intervention / Treatment
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* Other: Spray skin protector
* Other: moisturizer Dnativ Revita derm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with anal and rectal cancer with indication for radiotherapy and conventional fractionation of treatment in a linear accelerator; age > or = 18 years; no previous history of radiotherapy in the same field/site of treatment (reirradiation). - Exclusion Criteria:patients with pre-existing irradiated dermatitis, which makes skin assessment difficult; previous report of allergic reaction to any of the products used in the research. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After signing the Informed Consent Form, randomization will be carried out in two groups: Experimental, which will use the skin protector in spray and control, which will use the moisturizer Dnativ Revita Derm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Experimental<br>Participants who will use the spray skin protector | Other: Spray skin protector<br>* Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.<br>* Other names: barrier film to prevent radiodermatitis;|
| Active Comparator: Group control<br>Participants who will use moisturizer Dnativ Revita Derm. | Other: moisturizer Dnativ Revita derm<br>* Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.<br>* Other names: conventional treatment to prevent radiodermatitis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moist desquamation incidence | Moist desquamation incidence after the beginning of radiotherapy | from the first day of radiotherapy up to eight weeks | 
| Adverse events | Occurrence of adverse events after the beginning of radiotherapy | from the first day of radiotherapy up to eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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barrier film, spray skin protection, liquid-film, barrier product