3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-006813
NCT ID: NCT03546803
Sponsor Protocol Number: 17-006813
About this study
This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ivy Petersen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available