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

Radiodermatitis Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04067310
• Other study ID #: PROT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: January 20, 2023

Study information

• Verified date: October 2022
• Source: Instituto Nacional de Cancer, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 124
• Est. completion date: January 20, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Injury, Radiation
• Radiation Injuries
• Radiodermatitis

Intervention

Other:
• Spray skin protector
Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.
• moisturizer Dnativ Revita derm
Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.

Locations

Country	Name	City	State
Brazil	INCA Research Center	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moist desquamation incidence	Moist desquamation incidence after the beginning of radiotherapy	from the first day of radiotherapy up to eight weeks
Primary	Adverse events	Occurrence of adverse events after the beginning of radiotherapy	from the first day of radiotherapy up to eight weeks