StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck C… (NCT03394417) | Clinical Trial Compass
RecruitingNot Applicable
StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients
Singapore100 participantsStarted 2018-11-08
Plain-language 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.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.