Breast Cancer Clinical Trial
Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis
The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.
Age ≥ 18 years.
Histological confirmation of breast or chest wall malignancy
Primary or recurrent disease eligible
Post-mastectomy with or without reconstruction
Undergoing unilateral external beam radiotherapy at the Mayo Clinic - Rochester, MN or Mayo Clinic - Eau Claire, WI
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 6 weeks post-treatment for assessment
Able to initiate thin film usage within first 3 days of the initiation of treatment
Documented history of adhesive or tape allergy
Unable to provide written consent
Patients with prior radiotherapy to any portion of the planned treatment site
Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
Gross dermal involvement at initiation of radiotherapy
Recent use of systemic or topical antibiotics or antifungal medications within 14 days of swab collection
Recent use of any of the following within 14 days of swab collection:
Systemic or topical steroids
Use of systemic immunosuppressant drugs
Use of ultraviolet light therapy
Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
Prior organ or bone marrow transplant
Undergoing bilateral radiation
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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