Clinical trial NCT04067310: Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.
Official title: Randomized, Open-label Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis in Patients With Anal and Rectal Canal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiodermatitis
Injury, Radiation
Keywords: barrier film
spray skin protection
liquid-film
barrier product
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2019-08-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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).

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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.

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Primary outcomes:
measure: Number of Participants Categorized by RTOG Grading Scale
timeFrame: From the first day of radiotherapy up to eight weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: From the first day of radiotherapy up to eight weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: INCA Research Center
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro (UFRJ)
name: Fabiana V Simões
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro (UFRJ)
name: Rafael C Silva
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal Fluminense (UFF)
name: Beatriz G R B Oliveira
role: PRINCIPAL_INVESTIGATOR
References: