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StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients
Sponsor: National University Hospital, Singapore
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 of whom will be outpatients unless they require inpatient supportive care during treatment. There will be a 12 to 14-week longitudinal follow-up with 9 assessments conducted during this follow-up. The estimated duration of recruitment will be 6-8 years. Intervention group If a patient is allocated to the intervention group following randomization, the patient will be treated with StrataXRT. Control group If a patient is allocated to the control group following randomization, the patient will be treated with standard clinical practice which consists of aqueous cream.
Official title: StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers
Key Details
Gender
All
Age Range
21 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2018-11-08
Completion Date
2027-06
Last Updated
2024-12-12
Healthy Volunteers
No
Interventions
StrataXRT
randomized patient allocated to this group will receive StrataXRT for application during the treatment and 4 weeks further after the treatment ends.
Locations (1)
National University Hospital
Singapore, Singapore