N/A
N=72
Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.
Radiodermatitis · Injury, Radiation
Bottom Line
View on ClinicalTrials.gov: NCT04067310 ↗Enrolled (actual)
72
Serious AEs
1.6%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants Categorized by RTOG Grading Scale — 12; 6; 11; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spray skin protector (Other); moisturizer Dnativ Revita derm (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto Nacional de Cancer, Brazil
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Categorized by RTOG Grading Scale |
12; 6; 11; 11; 10; 11 | — |
| SECONDARY Adverse Events |
29; 23; 33; 28; 14; 12 | — |
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.
Eligibility Criteria
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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Data sourced from ClinicalTrials.gov (NCT04067310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.