Actively Recruiting
StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients
Led by National University Hospital, Singapore · Updated on 2024-12-12
100
Participants Needed
1
Research Sites
446 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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, such as connective tissue disorders
- 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 breastfeeding
- Unable to give written informed consent, or unable to have written consent given on their behalf
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
D
David Chia
CONTACT
F
Fatin Aliyah Binte Hussin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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