Radiation Dermatitis
Conditions
Brief summary
This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.
Interventions
OTHER3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Age ≥ 18years. * Patient has initial or recurrent disease * Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus Note: Patients who are undergoing concurrent chemotherapy are eligible * Ability to complete questionnaire(s) by themselves or with assistance * Provide informed written consent * Willing to consent for photography of radiation field * Available to return to Mayo Clinic in within 1 week post treatment for assessment (+/- 7 days). * At risk for developing ≥ grade 2 dermatitis radiation as determined by treating Radiation Oncology clinician * Biologic effective dose of \>42 Gy10 as calculated using the web site EQD2.com.
Exclusion criteria
* Unable to provide informed consent * Patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult * Known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates * Subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study * Subject has been 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 | Description |
|---|---|---|
| compare radiation dermatitis severity | 3 months (+/- 1 month) following the completion of radiation therapy | To compare radiation dermatitis severity in irradiated skin protected by a liquid skin protectant (3M™ Cavilon™ Advanced Skin Protectant) that rapidly dries versus uncovered skin (internal control) as determined by a panel. |
Countries
United States
Outcome results
None listed