NCT03394417 StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients
| NCT ID | NCT03394417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University Hospital, Singapore |
| Condition | Head and Neck Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-11-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2018-11-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
David Chia
PRINCIPAL INVESTIGATOR
National University Hospital, Singapore
Frequently Asked Questions
Who can join the NCT03394417 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Head and Neck Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03394417 currently recruiting?
Yes, NCT03394417 is actively recruiting participants. Contact the research team at david_chia@nuhs.edu.sg for enrollment information.
Where is the NCT03394417 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT03394417 clinical trial?
NCT03394417 is sponsored by National University Hospital, Singapore. The principal investigator is David Chia at National University Hospital, Singapore. The trial plans to enroll 100 participants.
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