NCT04067310

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Instituto Nacional de Cancer, Brazil · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiodermatitis
• Injury, Radiation

Interventions

Type	Name	Description
OTHER	Spray skin protector	Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.
OTHER	moisturizer Dnativ Revita derm	Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.

Timeline

• Start date: 2020-12-16
• Primary completion: 2022-12-30
• Completion: 2023-01-20
• First posted: 2019-08-26
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

1 site across 1 country: Brazil