Status:
COMPLETED
Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Collaborating Sponsors:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conditions:
Radiodermatitis
Injury, Radiation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tec...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04067310
Start Date
December 16 2020
End Date
January 20 2023
Last Update
December 9 2024
Active Locations (1)
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1
INCA Research Center
Rio de Janeiro, Rio de Janeiro, Brazil, 20231092