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

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ClinicalTrials.gov Identifier: NCT04149522
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mark Trombetta, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiotherapy; Adverse Effect, Dermatitis or Eczema Radiotherapy Side Effect Radiation Burn Radiation Dermatitis Radiotherapy; Complications Device: Mepitel Film® Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mepitel Film® Prophylaxis For Breast Cancer Patients Receiving Breast Radiotherapy At High Risk For Moist Desquamation: A Phase II Study
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Medial Breast Tissue
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®
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.

Active Comparator: Lateral Breast Tissue
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®
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.




Primary Outcome Measures :
  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 [ Time Frame: 7 weeks from initiation ]
    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.


Secondary Outcome Measures :
  1. Quality of Life (QOL) responses [ Time Frame: 7 weeks from initiation ]
    A QOL questionnaire will be completed by each patient prior to first radiation treatment and at weeks 3, 5 and 6 (which will occur if clinically indicated) of radiotherapy, and 1 week following the completion of irradiation. The questionnaire asks subjects to rate symptoms on a scale from 1 to 4 (1 being excellent or no side effect to 4 being poor or worst side effect). The symptoms include: nipple appearance, arm movement, breast tenderness, breast swelling, breast sensitivity, swelling of breast, breast warm to touch, breast skin is red, breast skin is tanned, breast skin is flaking or peeling, breast itching, blisters or breast skin moist and raw, sharp shooting pains in the breast. Subjects will also be asked to choose the word (with definition) that best describes how their breast looks (excellent, good, poor or fair). Data will be analyzed using McNemar's test to compare the pre/post differences in survey response. Analysis will be stratified by any significant confounders.

  2. Time until the onset of erythema [ Time Frame: 7 weeks from initiation ]
    Time until onset of erythema with and without the film will be measured in days, based upon physician's physical exam and assessments at baseline and at each follow up visit. 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.

  3. Time to healing skin treated with and without the film [ Time Frame: 7 weeks from initiation ]
    Time to healing skin treated with and without the film will be measured in days, based upon physician's physical exam and assessments at baseline and at each follow up visit. 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.

  4. Reduction in erythema [ Time Frame: 7 weeks from initiation ]
    Reduction in erythema will be measured in percent change, based upon physician's physical exam and assessments at baseline and at each follow up visit. 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.

  5. Reduction in moist desquamation [ Time Frame: 7 weeks from initiation ]
    Reduction in moist desquamation will be measured in percent change, based upon physician's physical exam and assessments at baseline and at each follow up visit. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women 18 - 80 years of age
  2. Biopsy-proven diagnosis of breast cancer with the breast tumor completely removed
  3. Whole breast or chest wall irradiation with or without ipsilateral axillary radiotherapy
  4. Women of child-bearing potential must use an effective form of birth control

Exclusion Criteria:

  1. Women who are pregnant or lactating
  2. 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®
  3. Women with a chest abnormality that would preclude application of the Film;
  4. Women who in the investigator's opinion are not capable of completing the trial or following trial procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149522


Contacts
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Contact: AHN Research Institute 412-330-6151 ClinicalTrials@ahn.org

Locations
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United States, Pennsylvania
Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Clinical Trials Contact    412-330-6151    clinicaltrials@ahn.org   
Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Investigators
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Principal Investigator: Mark Trombetta, MD AHN Research Institute
Additional Information:
Publications:
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Responsible Party: Mark Trombetta, MD, MD, Radiation Oncology, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT04149522    
Other Study ID Numbers: 2019-185-AGH
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mark Trombetta, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute):
Radiotherapy breast
Mepitel Film
Additional relevant MeSH terms:
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Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries