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NCT Number: NCT04067310

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

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.

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Key information

Conditions

Radiodermatitis Dermatitis Injury, Radiation Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INCA Research Center

Rio de Janeiro, 20231092, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Spray skin protector

Other

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

Other names: barrier film to prevent radiodermatitis

moisturizer Dnativ Revita derm

Other

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

Other names: conventional treatment to prevent radiodermatitis

Primary outcomes

  1. Number of Participants Categorized by RTOG Grading Scale

    Time frame: 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 outcomes

  1. Adverse Events

    Time frame: From the first day of radiotherapy up to eight weeks

    Occurrence of adverse events after the beginning of radiotherapy

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancer, Brazil

Other Gov

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 26, 2019
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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