Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Injury, Radiation | — | UNRESOLVED | — |
| Radiodermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| moisturizer Dnativ Revita derm | Other | — | UNRESOLVED |
| Spray skin protector | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group Experimental
- description
- Participants who will use the spray skin protector
- interventionNames
- Other: Spray skin protector
- type
- ACTIVE_COMPARATOR
- label
- Group control
- description
- Participants who will use moisturizer Dnativ Revita Derm.
- interventionNames
- Other: moisturizer Dnativ Revita derm
Primary outcomes (1)
- measure
- Number of Participants Categorized by RTOG Grading Scale
- timeFrame
- From the first day of radiotherapy up to eight weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. \-
References
Publications (0)
Data not yet available