Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis

Breast Cancer Clinical Trial

Official title:

Evaluating the Efficacy of Mepitel in Post-mastectomy Breast Cancer Patients, and Examining the Role of the Skin Microbiome in Radiation Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519438
• Other study ID #: 17-001546
• Secondary ID: ROR1701
• Status: Completed
• Start date: April 11, 2018
• Est. completion date: November 25, 2019

Study information

• Verified date: May 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Dermatitis
• Radiodermatitis

Intervention

Other:
• Mepitel
Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment		12 weeks
Primary	changes in the skin microbiome that occur secondary to ionizing radiation including quantitative analysis of S. aureus		12 weeks
Primary	changes in the skin microbiome of patients who use Mepitel including quantitative analysis of S. aureus		12 weeks

External Links

•   Mayo Clinic Clinical Trials