Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer

NCT04149522 | Terminated Phase 2 DMC FDA Device

• 1 other identifier: 2019-185-AGH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film is not made with natural rubber latex (NRL). It is FDA approved for the management of superficial wounds, such as superficial burns. As a part of this research study, the Mepitel Film® will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film® helps prevent skin breakdown. The subjects will be followed per standard of care and examined for skin redness, warmth or swelling as normally examined and cared for during standard radiation therapy. If radiation burns are noted, the subject will be treated normally and depending on the severity of the radiation burns, may be removed from the study treatment and treated through standard of care.

Conditions

Breast Cancer; Radiotherapy; Adverse Effect, Dermatitis or Eczema; Radiotherapy Side Effect; Radiation Burn; Radiation Dermatitis; Radiotherapy; Complications

Keywords

Radiotherapy breast; Mepitel Film

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of use of Mepitel Film® in the prevention of grade II or higher radiation epidermitis in high-risk patients undergoing radiotherapy for breast cancer

  The breast will be photographed and assessed at the beginning of therapy and at weeks 3, 5 and 6 the 3 (which will occur if clinically indicated) and one week following the completion of therapy. At each treatment, the breast will be evaluated by a physician for signs of infection, erythema, induration, dry or wet desquamation or frank skin breakdown, utilizing a Radiation Dermitis scale (NCI CTCAE v4.03) at each visit. The scale ranges from 0 to 4, with 0-being no change, 1-faint erythema or dry desquamation, 2-moderate to brisk erythema, 3-confluent moist desquamation, 4-skin necrosis or ulceration, as assessed by the physician. The primary analysis will be based on the classification of radiation dermatitis from treated and untreated skin at each visit and will be analyzed using a chi-square or Fisher's Exact test as appropriate. Analysis will be stratified by any significant confounding factors or effect modifiers.

  7 weeks from initiation

Secondary Outcomes (5)

• Quality of Life (QOL) responses

  7 weeks from initiation

• Time until the onset of erythema

  7 weeks from initiation

• Time to healing skin treated with and without the film

  7 weeks from initiation

• Reduction in erythema

  7 weeks from initiation

• Reduction in moist desquamation

  7 weeks from initiation

Study Arms (2)

Medial Breast Tissue

ACTIVE COMPARATOR

Women assigned to the medial breast tissue arm, will have the area of the breast visually divided into 2 equal parts; medial and lateral. The film will be applied to the medial breast tissue by clinically trained staff on day 1 of radiotherapy, the lateral segment will not be covered. The treatment area is cleaned with mild soap, rinsed with water, and dried. The film is applied, sticky side to the skin, then the paper frame is removed. Multiple sheets of non-overlapping film will be used to adequately cover the treatment area. During course of radiotherapy, new film may be applied by clinically trained staff in the event the film no longer adheres to the skin or comes off. Replacement of the film may be done as often as necessary. If there are signs of infection (e.g. redness, feeling warm or swollen), film can be removed. The film will remain in place until one week following the last day of radiotherapy, where it will be removed by the physician or clinically trained staff.

Device: Mepitel Film®

Lateral Breast Tissue

ACTIVE COMPARATOR

Women assigned to the lateral breast tissue arm will have the area of the breast visually divided into 2 equal parts; medial and lateral. The film will be applied to the lateral breast tissue only, by trained staff on day 1 of radiotherapy. The in-field ipsilateral axilla will be included with lateral breast segment to extent necessary to cover breast or chest wall only. The skin is cleaned with mild soap, rinsed with water, and dried. The film is applied, sticky side to skin and paper frame is removed. Multiple sheets of non-overlapping film will be used to cover the treatment area. During course of therapy, new film may be applied as often as necessary, by trained staff if film no longer adheres to skin or comes off. If there are signs of infection (e.g. redness, feeling warm or swollen), the film can be removed. The film will remain in place until one week following the last day of radiotherapy, where it will be removed by the physician or trained staff.

Device: Mepitel Film®

Interventions

Mepitel Film® DEVICE

As a part of this research study, Mepitel Film® will be placed prior to a participant's first radiation treatment, and will be removed one week following the end of treatment. The Film will be placed by the physician or his/her designee to cover approximately one-half of the breast divided in the cephalo-caudal plane. The film will remain in place until one week following the completion of radiotherapy. Any loss of film applied will be replaced as needed. Application of the Film is done by research personnel clinically trained in its application procedures.

Lateral Breast Tissue; Medial Breast Tissue

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 - 80 years of age
• Biopsy-proven diagnosis of breast cancer (Stage 0 - II) with the breast tumor completely removed
• Whole breast or chest wall irradiation with or without ipsilateral axillary radiotherapy
• Women of child-bearing potential must use an effective form of birth control

You may not qualify if:

• Women who are pregnant or lactating
• Women with evident skin irritation or skin infection (i.e. active rash, pre-existing dermatitis) or known allergy to adhesives or tapes; or known allergy to the Mepitel Film®
• Women with a chest abnormality that would preclude application of the Film;
• Women who in the investigator's opinion are not capable of completing the trial or following trial procedures

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (5)

AHN Cancer Institute at Jefferson Hospital

Clairton, Pennsylvania, 15025, United States

Location

AHN Cancer Institute Forbes

Monroeville, Pennsylvania, 15146, United States

Location

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

AHN West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

AHN Wexford Health + Wellness Pavilion

Wexford, Pennsylvania, 15090, United States

Location

Related Publications (1)

• Herst PM, Bennett NC, Sutherland AE, Peszynski RI, Paterson DB, Jasperse ML. Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. Radiother Oncol. 2014 Jan;110(1):137-43. doi: 10.1016/j.radonc.2014.01.005. Epub 2014 Jan 30.

  PMID: 24486117 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Dermatitis; Eczema; Radiation Injuries; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Wounds and Injuries

Study Officials

• Mark Trombetta, MD

  AHN Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Radiation Oncology

Model Details: 2 study arms - 20 women to receive Mepitel film on medial aspect of breast, 20 women to receive Mepitel film on lateral aspect of breast

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 4, 2019
• Study Start: January 15, 2020
• Primary Completion: August 31, 2023
• Study Completion: November 6, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

US (5)