Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT03546803
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)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03546803
Study Brief:
Protocol Section:
NCT03546803