RecruitingNot ApplicableNCT03394417

StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients

StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers

Sponsor

National University Hospital, Singapore

Enrollment

100 participants

Start Date

Nov 8, 2018

Study Type

INTERVENTIONAL

Conditions

Acute Radiation Dermatitis Head and Neck Cancers

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.

Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a silicone-based gel product called StrataXRT applied to the skin against standard clinical care to see which approach better prevents or reduces radiation-related skin irritation (dermatitis) in patients with head and neck cancers undergoing combined radiation and chemotherapy. **You may be eligible if...** - You are 21 years or older - You have been diagnosed with a head and neck cancer confirmed by tissue testing - You are scheduled to receive both radiation therapy and chemotherapy at the same time (chemoradiation) - Your overall health is acceptable (ECOG performance status 0 to 3) - You have no known allergy to StrataXRT or silicone products - You are able to give written informed consent **You may NOT be eligible if...** - You cannot apply the skin product yourself or have it applied by a caregiver - You have conditions or take medications that may already affect your skin's reaction (such as connective tissue diseases) - You are allergic to silicone or the product's ingredients Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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