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

Launched by NATIONAL UNIVERSITY HOSPITAL, SINGAPORE · Jan 7, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether a product called StrataXRT can help prevent skin irritation, known as acute radiation dermatitis, in patients undergoing treatment for head and neck cancers. Patients in the trial will be randomly assigned to either receive StrataXRT or standard treatment with an aqueous cream. The study will follow participants for about 12 to 14 weeks, with several assessments to monitor their skin and overall health during this time.

To participate in the trial, individuals must be 21 years or older, have a confirmed diagnosis of head and neck cancer, and be scheduled to receive chemoradiation therapy. There are some conditions that might exclude someone from participating, such as having a skin rash in the treatment area or being pregnant. Overall, this trial aims to see if StrataXRT can offer better protection for patients' skin compared to the usual care method.

Gender

ALL

Eligibility criteria

• 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