Status:
RECRUITING
StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Head and Neck Cancers
Acute Radiation Dermatitis
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
This is a phase IV, prospective, double-blind, randomized controlled trial with 2 study arms. The study population will be patients receiving chemoradiation for head and neck carcinomas, the majority ...
Detailed Description
Clinical significance and current evidence: Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal cancer; 50 to 60% develop grade 2 or higher dermatitis. This c...
Eligibility Criteria
Inclusion
- patients who are 21 years of age or older
- histological diagnosis of head and neck carcinoma available
- patients who are to be treated with concurrent chemoradiation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- no known allergy to StrataXRT or silicone
- able to give written informed consent, or have written consent given on their behalf
Exclusion
- patients who cannot apply the skin product or have it administered to them
- patients with comorbidities and/or on medications that may alter the response of the skin e.g. connective tissue disorder
- patients with existing rashes or wounds in the radiation field at baseline
- patients receiving concurrent cetuximab during radiotherapy
- previous radiotherapy to the head and neck region
- female patients who are pregnant or breast feeding
- unable to give written informed consent , or are unable to have written consent given on their behalf
Key Trial Info
Start Date :
November 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03394417
Start Date
November 8 2018
End Date
June 1 2027
Last Update
December 12 2024
Active Locations (1)
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1
National University Hospital
Singapore, Singapore