Status:
TERMINATED
Feasibility in the Prophylaxis of Radiation Dermatitis Severity
Lead Sponsor:
Mayo Clinic
Conditions:
Radiation Dermatitis
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04715386
Start Date
June 22 2020
End Date
January 30 2024
Last Update
February 9 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905