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.
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
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
Parallel
StrataXRT
Devicerandomized patient allocated to this group will receive StrataXRT for application during the treatment and 4 weeks further after the treatment ends.
grade 2 acute radiation dermatitis
when patient develops grade 2 acute radiation dermatitis as scored by Common Terminology Criteria for Adverse Event (CTCAE) version 4.03 scale with grade 1 the mildest, Grade 1: faint erythema or dry desquamation Grade 2: moderate to brisk erythema; patchy moist desquamation; moderate edema Grade 3: moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site Grade 5: death
completion of scheduled post-treatment assessment at 6 weeks post-radiotherapy
when patient completed the scheduled post-radiotherapy assessment
Click on the lead sponsor to view all of their trials.
