Breast CancerPhase 2NCT04149522
Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer
A Phase 2 study testing Mepitel Film® in people with Breast Cancer and Radiotherapy; Adverse Effect, Dermatitis or Eczema, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Radiotherapy; Adverse Effect, Dermatitis or Eczema, Radiotherapy Side Effect
- What is being tested?
- Mepitel Film®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jan 2020to 6 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
AHN Cancer Institute at Jefferson Hospital
Clairton, Pennsylvania, 15025
AHN Cancer Institute Forbes
Monroeville, Pennsylvania, 15146
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
AHN Wexford Health + Wellness Pavilion
Wexford, Pennsylvania, 15090
About this study
Official title: Mepitel Film® Prophylaxis For Breast Cancer Patients Receiving Breast Radiotherapy At High Risk For Moist Desquamation: A Phase II Study
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.
Read the 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 Article(s) 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 subject's 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 R\&D. 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 inclusion/exclusion 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.
- Conditions
- Breast Cancer, Radiotherapy; Adverse Effect, Dermatitis or Eczema, Radiotherapy Side Effect, Radiation Burn, Radiation Dermatitis, Radiotherapy; Complications
- Being tested
- Mepitel Film®
- Keywords
- Radiotherapy breast, Mepitel Film
- Medical subject headings
- Breast Neoplasms, Dermatitis, Eczema, Radiation Injuries, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Mepitel Film® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks from initiation
Secondary outcomes (5)
Quality of Life (QOL) responses
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.
Measured: 7 weeks from initiation
Time until the onset of erythema
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.
Measured: 7 weeks from initiation
Time to healing skin treated with and without the film
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.
Measured: 7 weeks from initiation
Reduction in erythema
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.
Measured: 7 weeks from initiation
Reduction in moist desquamation
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.
Measured: 7 weeks from initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start15 Jan 2020
- Primary completion31 Aug 2023
- Study completion6 Nov 2023
Why it stopped: The mepitel film was expired and was no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Trombetta, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Mark Trombetta, MD, Principal investigator, AHN Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149522
- Sponsor's protocol ID
- 2019-185-AGH
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2019
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 24486117
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepitel Film® Prophylaxis For Breast Cancer Patients Receiving Breast Radiotherapy At High Risk For Moist Desquamation: A Phase II Study
- ClinicalTrials.gov ID
- NCT04149522
- Acronym / sponsor ID
- 2019-185-AGH
- Conditions
- Breast Cancer, Radiotherapy; Adverse Effect, Dermatitis or Eczema, Radiotherapy Side Effect, Radiation Burn, Radiation Dermatitis, Radiotherapy; Complications
- Keywords
- Radiotherapy breast, Mepitel Film
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The mepitel film was expired and was no longer available.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Article(s) 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 subject's 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 R\&D. 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 inclusion/exclusion 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Medial Breast Tissue | Active comparator | Device: Mepitel Film®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. |
| Lateral Breast Tissue | Active comparator | Device: Mepitel Film®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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Lateral Breast Tissue, Medial Breast Tissue |
Primary outcome
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.
5 secondary outcomes
Quality of Life (QOL) responses
Time frame: 7 weeks from initiation
Time until the onset of erythema
Time frame: 7 weeks from initiation
Time to healing skin treated with and without the film
Time frame: 7 weeks from initiation
Reduction in erythema
Time frame: 7 weeks from initiation
Reduction in moist desquamation
Time frame: 7 weeks from initiation
Results and safety
The study was stopped early (reason given: The mepitel film was expired and was no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 24486117Herst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Trombetta, MD principal investigator
AHN Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mepitel Film® in people with Breast Cancer and Radiotherapy; Adverse Effect, Dermatitis or Eczema, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The mepitel film was expired and was no longer available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04149522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.