Comparing StrataXRT to standard care for preventing skin issues in head and neck cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of StrataXRT, a silicone-based gel, in preventing acute radiation dermatitis in patients undergoing chemoradiation for head and neck cancers. It is a phase IV, prospective, double-blind, randomized controlled trial involving two groups: one receiving StrataXRT and the other receiving standard care with aqueous cream. Participants will be followed for 12 to 14 weeks with multiple assessments to determine the incidence and severity of dermatitis. The study aims to provide clearer evidence on the best preventive measures for this common side effect of treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• National University Hospital
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: David Chia — National University Hospital, Singapore
• Study coordinator: David Chia
• Email: david_chia@nuhs.edu.sg
• Phone: 67737888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.