Radiation Dermatitis Clinical Trial
Official title:
Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients
Verified date | February 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs. | First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days | ||
Secondary | Patient reported outcomes | Patients will be asked to complete a survey at the end of study that will ask them to provide feedback on the agent used during their treatment. | Upon study completion, on average 6 weeks, but will vary per patient |
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