Feasibility in the Prophylaxis of Radiation Dermatitis Severity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-22

Study Completion Date

2024-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Radiation Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1- StrataXRT

StrataXRT

Intervention Type DRUG

Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.

Interventions

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StrataXRT

Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No