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

Not Applicable

Completed

• Conditions: Injury, Radiation; Radiodermatitis
• Interventions: Other: Spray skin protector; Other: moisturizer Dnativ Revita derm

• Registration Number: NCT04067310
• Lead Sponsor: Instituto Nacional de Cancer, Brazil

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.

Study Timeline

• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Study Start: 2020-12-16
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-20
• Results First Submitted: 2023-04-17
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Results First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Experimental	Spray skin protector	Participants who will use the spray skin protector
Group control	moisturizer Dnativ Revita derm	Participants who will use moisturizer Dnativ Revita Derm.

Primary Outcome Measures

Name	Time	Method
Number of Participants Categorized by RTOG Grading Scale	From the first day of radiotherapy up to eight weeks	RTOG ACUTE Radiation Morbidity - Tissue: Skin; * Grade 1: Follicular, faint or dull erythema / epilation / dry desquamation / decreased sweating; * Grade 2: Tender or bright erythema, patchy moist desquamation / moderate edema; * Grade 3: Confluent, moist desquamation other than skin folds, pitting edema; * Grade 4: Ulceration, hemorrhage, necrosis.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	From the first day of radiotherapy up to eight weeks	Occurrence of adverse events after the beginning of radiotherapy

Trial Locations

Locations (1)

INCA Research Center; 🇧🇷 Rio de Janeiro, RJ, Brazil