Comparing StrataXRT to standard care for preventing skin issues in head and neck cancer patients
StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers
This study is testing if a new silicone gel called StrataXRT can help prevent skin problems in patients with head and neck cancer who are getting radiation treatment, compared to the usual cream they receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | cetuximab, radiation, chemotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT03394417 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with a histological diagnosis of head and neck carcinoma who are scheduled to receive concurrent chemoradiation.
Not a fit: Patients with existing skin conditions in the radiation field or those receiving certain concurrent treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of acute dermatitis, improving the quality of life for patients undergoing treatment for head and neck cancers.
How similar studies have performed: While current literature lacks conclusive evidence on the best agents for preventing radiation dermatitis, this study's approach is novel and aims to fill that gap.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.