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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Radiodermatitis; Injury, Radiation
• Intervention / Treatment: Other: Spray skin protector; Other: moisturizer Dnativ Revita derm

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.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20231092
      • INCA Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cancer, Brazil
• Investigators: Principal Investigator: Fabiana Simões, MD, Universidade Federal do Rio de Janeiro (UFRJ); Principal Investigator: Rafael Co-orientador, PhD, Universidade Federal do Rio de Janeiro (UFRJ); Principal Investigator: Beatriz Co-orientadora, PhD, Universidade Federal Fluminense (UFF)

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): January 20, 2023

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: barrier film; spray skin protection; liquid-film; barrier product
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Dermatitis; Radiation Injuries; Radiodermatitis
• Other Study ID Numbers: PROT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No