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

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

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions3

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