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Mepitel Film for Radiation Dermatitis in Breast Cancer Patients

Phase 2

Waitlist Available

Led By Mark Trombetta, MD

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 weeks from initiation

Awards & highlights

Study Summary

This trial is testing whether Mepitel Film can help prevent skin breakdown from radiation therapy in breast cancer patients.

Eligible Conditions

Radiation Skin Damage
Radiotherapy Side Effects
Radiotherapy Dermatitis or Radiotherapy Eczema
Radiation Burn
Radiotherapy Complications
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 weeks from initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 weeks from initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks from initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breast

Secondary outcome measures

Quality of Life (QOL) responses

Reduction in erythema

Reduction in moist desquamation

+2 more

Trial Design

2Treatment groups

Active Control

Group I: Medial Breast TissueActive Control1 Intervention

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.

Group II: Lateral Breast TissueActive Control1 Intervention

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.

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Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor

47 Previous Clinical Trials

13,039 Total Patients Enrolled

Mark Trombetta, MDPrincipal Investigator - AHN Research Institute

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Mepitel Film® (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04149522 — Phase 2

Radiation Skin Damage Research Study Groups: Medial Breast Tissue, Lateral Breast Tissue

Radiation Skin Damage Clinical Trial 2023: Mepitel Film® Highlights & Side Effects. Trial Name: NCT04149522 — Phase 2

Mepitel Film® (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04149522 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to geriatric individuals?

"To be eligible for this medical study, potential participants must fall between the age of 18 and 80. Alternatively, there are 170 clinical trials available specifically for those below 18 years old as well as 2683 trials targeting patients 65 or older."

Answered by AI

Who is eligible to take part in this clinical trial?

"To be eligible for the trial, potential participants should have been diagnosed with breast cancer and must fall between 18-80 years old. Approximately 40 individuals are being sought after to partake in this research."

Answered by AI

Are a plurality of clinical centers administering this trial in the local area?

"The AHN Cancer Institute at Jefferson Hospital in Clairton, the AHN West Penn Hospital in Pittsburgh, and the AHN Wexford Health + Wellness Pavilion in Wexford are 3 of 5 clinical trial sites. There are 2 additional recruiting locations as well."

Answered by AI

What is the size of the cohort engaged in this research study?

"Affirmative, clinicaltrials.gov confirms that this study is presently enrolling. It was initially posted on the 15th of January 2020 and edited most recently on July 18th 2022 with a required sample size of 40 patients from 5 different locations."

Answered by AI

Does the FDA accredit Medial Breast Tissue?

"Our internal assessment at Power assigned a score of 2 to Medial Breast Tissue because it is in Phase 2, meaning there are supporting safety data but no evidence yet for efficacy."

Answered by AI

Are any slots available to join this clinical experiment?

"According to information posted on clinicaltrials.gov, this study is actively recruiting patients; it was published in January 2020 and updated most recently at the end of July 2022."

Answered by AI

Recent research and studies

Radiotherapy and OncologyJournal

Prophylactic Use of Mepitel Film Prevents Radiation-induced Moist Desquamation in an Intra-patient Randomised Controlled Clinical Trial of 78 Breast Cancer Patients

Herst, Patries M., Noelle C. Bennett, Annie E. Sutherland, Ruth I. Peszynski, Dean B. Paterson, and Marieke L. Jasperse. 2014. “Prophylactic Use of Mepitel Film Prevents Radiation-induced Moist Desquamation in an Intra-patient Randomised Controlled Clinical Trial of 78 Breast Cancer Patients”. Radiotherapy and Oncology. Elsevier BV. doi:10.1016/j.radonc.2014.01.005.

clinicaltrials.govStudy

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

Mark Trombetta, MD 2020. "Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04149522.