Radiation Dermatitis
Conditions
Brief summary
To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.
Interventions
DRUGStrataXRT
Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18years * Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus. Note: patients undergoing concurrent chemotherapy are eligible. * Able to provide informed written consent * Willing to consent for photography of radiation field * Receiving a dose ≥ 45 Gy and 20 fractions to both the area being treated and the area being used for comparison
Exclusion criteria
* Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion. * Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields. * Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study. * Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit * The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs. | First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcomes | Upon study completion, on average 6 weeks, but will vary per patient | Patients will be asked to complete a survey at the end of study that will ask them to provide feedback on the agent used during their treatment. |
Countries
United States
Outcome results
None listed