Feasibility in the Prophylaxis of Radiation Dermatitis Severity

Mayo Clinic

Status: Terminated

Conditions: Radiation Dermatitis

Treatments: Drug: StrataXRT

Study type: Observational

Funder types: Other

Identifiers

NCT04715386

19-007541

NCI-2023-00638 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

14 participants in 1 patient group

Group 1- StrataXRT

Treatment:

Drug: StrataXRT