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

Primary Purpose

Radiodermatitis, Injury, Radiation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Spray skin protector
moisturizer Dnativ Revita derm
Sponsored by
Instituto Nacional de Cancer, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiodermatitis focused on measuring barrier film, spray skin protection, liquid-film, barrier product

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • INCA Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Experimental

Group control

Arm Description

Participants who will use the spray skin protector

Participants who will use moisturizer Dnativ Revita Derm.

Outcomes

Primary Outcome Measures

Moist desquamation incidence
Moist desquamation incidence after the beginning of radiotherapy
Adverse events
Occurrence of adverse events after the beginning of radiotherapy

Secondary Outcome Measures

Full Information

First Posted
August 20, 2019
Last Updated
October 10, 2022
Sponsor
Instituto Nacional de Cancer, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT04067310
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancer, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiodermatitis, Injury, Radiation
Keywords
barrier film, spray skin protection, liquid-film, barrier product

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Blinding will be in skin evaluation and statistical analysis.
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Experimental
Arm Type
Experimental
Arm Description
Participants who will use the spray skin protector
Arm Title
Group control
Arm Type
Active Comparator
Arm Description
Participants who will use moisturizer Dnativ Revita Derm.
Intervention Type
Other
Intervention Name(s)
Spray skin protector
Other Intervention Name(s)
barrier film to prevent radiodermatitis
Intervention Description
Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.
Intervention Type
Other
Intervention Name(s)
moisturizer Dnativ Revita derm
Other Intervention Name(s)
conventional treatment to prevent radiodermatitis
Intervention Description
Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.
Primary Outcome Measure Information:
Title
Moist desquamation incidence
Description
Moist desquamation incidence after the beginning of radiotherapy
Time Frame
from the first day of radiotherapy up to eight weeks
Title
Adverse events
Description
Occurrence of adverse events after the beginning of radiotherapy
Time Frame
from the first day of radiotherapy up to eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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). - 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabiana Simões, MD
Organizational Affiliation
Universidade Federal do Rio de Janeiro (UFRJ)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafael Co-orientador, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro (UFRJ)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beatriz Co-orientadora, PhD
Organizational Affiliation
Universidade Federal Fluminense (UFF)
Official's Role
Principal Investigator
Facility Information:
Facility Name
INCA Research Center
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20231092
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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