Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04149522
Status:
TERMINATED
Last Update Posted:
2023-11-08
First Post:
2019-10-22
Brief Title:
Evaluation of Mepitel Film in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer
Sponsor:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Organization:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Study Overview
Official Title:
Mepitel Film Prophylaxis For Breast Cancer Patients Receiving Breast Radiotherapy At High Risk For Moist Desquamation A Phase II Study
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The mepitel film was expired and was no longer available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants 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
Detailed Description:
Clinical Phase II trial to determine if Mepitel Film is a viable prophylactic option for high-risk women undergoing radiotherapy for breast cancer to reduce side effects of radiation on the skin
The objective of this study is to 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
Test Articles Mepitel Film
The proposed study is a cohort trial of women with breast cancer who are at a high risk of having pain swelling inflammation with skin tenderness skin ulceration pruritis and scarring during radiation treatment
Each subjects participation will last approximately eight weeks The entire study is expected to last up to 24 months
The primary analysis will be based classification of radiation dermatitis from treated and untreated skin at each visit Secondary endpoints will review quality of life responses compared to dermatitis
Statistical analysis will be completed by Highmark Health Data Science RD The principal investigator will share any updates AEs and safety concerns to the Data Safety Monitoring Board DSMB a group of scientists physicians statisticians and others that collect and analyze data during the course of a research study to monitor for adverse events and other trends that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial The Highmark Health Data Science Research and Development department are the statisticians for this study and will participate on the DSMB
General Schema of Study Design Women who meet inclusionexclusion for the trial and are consent to participate in the trial are enrolled in the study Prior to standard of care radiation treatments women will have the area of the breast divided into two approximately equal parts medial and lateral The in-field ipsilateral axilla will be included with the lateral breast segment to the extent necessary for coverage of the breast or chest wall only The infra-mammary crease will be part of both the medial and lateral breast segments Axillary irradiation is allowed and the nodal areas irradiated should be considered as part of the evaluable field and covered with the Film as required by division of the breast as above The aspect of the breast covered by the Mepitel Film will alternate with consecutive patients and the axilla will be separately evaluated for acute reaction Each woman will act as her own control The breast will be photographed digital images At each treatment the breast will be evaluated for signs of infection erythema induration dry or wet desquamation or frank skin breakdown A Quality-Of-Life QOL Instrument will be completed by the patient
All radiotherapy visits are standard of care for participants The Mepitel Film has been purchased for this study by the Allegheny General Hospital AGH Auxiliary and each box of Film received will be then labeled for investigational use only
Study Duration Enrollment and Number of Sites Length of time on study is dependent upon the radiotherapy regimen 25 fractions or 28 fractions and any AE probably or definitely related to study participation The expected length of time on study is 6 - 7 weeks 25 to 28 business days Monday-Friday for the radiotherapy plus the one week post treatment follow up visit Visits related to an adverse event AE will continue until the AE is resolved which may extend participation time
The study will be conducted at approximately 5 investigative sites in the Allegheny Health Network and the accrual goal is 40 women
The objective of this study is to 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
Test Articles Mepitel Film
The proposed study is a cohort trial of women with breast cancer who are at a high risk of having pain swelling inflammation with skin tenderness skin ulceration pruritis and scarring during radiation treatment
Each subjects participation will last approximately eight weeks The entire study is expected to last up to 24 months
The primary analysis will be based classification of radiation dermatitis from treated and untreated skin at each visit Secondary endpoints will review quality of life responses compared to dermatitis
Statistical analysis will be completed by Highmark Health Data Science RD The principal investigator will share any updates AEs and safety concerns to the Data Safety Monitoring Board DSMB a group of scientists physicians statisticians and others that collect and analyze data during the course of a research study to monitor for adverse events and other trends that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial The Highmark Health Data Science Research and Development department are the statisticians for this study and will participate on the DSMB
General Schema of Study Design Women who meet inclusionexclusion for the trial and are consent to participate in the trial are enrolled in the study Prior to standard of care radiation treatments women will have the area of the breast divided into two approximately equal parts medial and lateral The in-field ipsilateral axilla will be included with the lateral breast segment to the extent necessary for coverage of the breast or chest wall only The infra-mammary crease will be part of both the medial and lateral breast segments Axillary irradiation is allowed and the nodal areas irradiated should be considered as part of the evaluable field and covered with the Film as required by division of the breast as above The aspect of the breast covered by the Mepitel Film will alternate with consecutive patients and the axilla will be separately evaluated for acute reaction Each woman will act as her own control The breast will be photographed digital images At each treatment the breast will be evaluated for signs of infection erythema induration dry or wet desquamation or frank skin breakdown A Quality-Of-Life QOL Instrument will be completed by the patient
All radiotherapy visits are standard of care for participants The Mepitel Film has been purchased for this study by the Allegheny General Hospital AGH Auxiliary and each box of Film received will be then labeled for investigational use only
Study Duration Enrollment and Number of Sites Length of time on study is dependent upon the radiotherapy regimen 25 fractions or 28 fractions and any AE probably or definitely related to study participation The expected length of time on study is 6 - 7 weeks 25 to 28 business days Monday-Friday for the radiotherapy plus the one week post treatment follow up visit Visits related to an adverse event AE will continue until the AE is resolved which may extend participation time
The study will be conducted at approximately 5 investigative sites in the Allegheny Health Network and the accrual goal is 40 women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None