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

NCT ID: NCT04067310

Last Updated: 2024-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-16

Study Completion Date

2023-01-20

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.

Conditions

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Radiodermatitis Injury, Radiation

Keywords

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barrier film spray skin protection liquid-film barrier product

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Blinding will be in skin evaluation and statistical analysis.

Study Groups

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Group Experimental

Participants who will use the spray skin protector

Group Type EXPERIMENTAL

Spray skin protector

Intervention Type OTHER

Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.

Group control

Participants who will use moisturizer Dnativ Revita Derm.

Group Type ACTIVE_COMPARATOR

moisturizer Dnativ Revita derm

Intervention Type OTHER

Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.

Interventions

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Spray skin protector

Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.

Intervention Type OTHER

moisturizer Dnativ Revita derm

Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.

Intervention Type OTHER

Other Intervention Names

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barrier film to prevent radiodermatitis conventional treatment to prevent radiodermatitis

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Fabiana Verdan Simões

Principal Research Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabiana V Simões

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro (UFRJ)

Rafael C Silva

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro (UFRJ)

Beatriz G R B Oliveira

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal Fluminense (UFF)

Locations

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INCA Research Center

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PROT

Identifier Type: -

Identifier Source: org_study_id