Clinical trial NCT03519438: Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis
Official title: Evaluating the Efficacy of Mepitel in Post-mastectomy Breast Cancer Patients, and Examining the Role of the Skin Microbiome in Radiation Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: post-mastectomy breast cancer patients

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Documented history of adhesive or tape allergy
* Unable to provide written consent
* Patients with prior radiotherapy to any portion of the planned treatment site
* Brachytherapy patients
* 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
* Current lactation
* Undergoing bilateral radiation

Primary outcomes:
measure: severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment
timeFrame: 12 weeks
measure: changes in the skin microbiome that occur secondary to ionizing radiation including quantitative analysis of S. aureus
timeFrame: 12 weeks
measure: changes in the skin microbiome of patients who use Mepitel including quantitative analysis of S. aureus
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kimberly Corbin, MD
role: PRINCIPAL_INVESTIGATOR
References: