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

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Mepitel

Study type: Observational

Funder types: Other

Identifiers

NCT03519438

ROR1701 (Other Identifier)

17-001546

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Lateral 3/4 of treatment field

Description:

placement of Mepitel on the lateral ¾ of the treatment field

Treatment:

Other: Mepitel

Medial 3/4 of treatment field

Description:

placement of Mepitel on the medial ¾ of the treatment field

Treatment:

Other: Mepitel