3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis

Study Overview
=================
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.

Official Title
-----------------
Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients

Conditions
-----------------
Radiation Dermatitis

Intervention / Treatment
-----------------
* Other: 3M™ Cavilon™ Advanced Skin Protectant


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Head and Neck Patients; Photon or Proton Treatment with product | Other: 3M™ Cavilon™ Advanced Skin Protectant<br>* liquid skin protectant on skin to protect from radiation dermatitis<br>|
| Cohort B<br>Hair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product | Other: 3M™ Cavilon™ Advanced Skin Protectant<br>* liquid skin protectant on skin to protect from radiation dermatitis<br>|
| Cohort C<br>Misc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care | Other: 3M™ Cavilon™ Advanced Skin Protectant<br>* liquid skin protectant on skin to protect from radiation dermatitis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare radiation dermatitis severity | 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. | 3 months (+/- 1 month) following the completion of radiation therapy |