Breast CarcinomaPhase 3NCT04989504

Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

A Phase 3 study testing Best Practice, Wound Dressing Material and Quality-of-Life Assessment in people with Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 49 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Carcinoma
What is being tested?: Best Practice, Wound Dressing Material and Quality-of-Life Assessment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 49 sitesUnited States
Study dates: 26 Jul 2022to 15 Feb 2029
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologic confirmation of breast malignancy with TNM staging.
Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy.
No prior radiotherapy to any portion of the planned treatment site.
No documented history of adhesive or tape allergy.
Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible.
No active rash or pre-existing dermatitis within the treatment field.

Show all 14Show fewer

No co-existing medical conditions resulting in life expectancy < 2 years.
No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis).
No concomitant cytotoxic chemotherapy. Endocrine therapy and HER2 directed therapies are allowed.
No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy.
No previous history of organ or bone marrow transplant.
Age >= 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
In order to complete the mandatory patient-completed measures, participants must be able to speak and read English.

Who cannot join

None listed.

Trial locations and contacts

49 sites in 1 country.

City, postcode or hospital

49 sites in 1 country

United States49 sites

McFarland Clinic - Ames
Ames, Iowa, 50010
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Anne Arundel Medical Center
Annapolis, Maryland, 21401
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
John Fitzgerald Kennedy Medical Center
Atlantis, Florida, 33462
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Beebe South Coastal Health Campus
Frankford, Delaware, 19945
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Glens Falls Hospital
Glens Falls, New York, 12801
Altru Cancer Center
Grand Forks, North Dakota, 58201
Saint Francis Hospital
Greenville, South Carolina, 29601
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Doctor's Hospital of Laredo
Laredo, Texas, 78041
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Fremont - Rideout Cancer Center
Marysville, California, 95901
Holy Redeemer Hospital and Medical Center
Meadowbrook, Pennsylvania, 19046
MUSC Health Tidelands Health Radiation Therapy Center
Murrells Inlet, South Carolina, 29576
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Mercy Hospital Springfield
Springfield, Missouri, 65804
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
UM Saint Joseph Medical Center
Towson, Maryland, 21204
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Dickstein Cancer Treatment Center
White Plains, New York, 10601
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494

Other trials in United States

About this study

Official title: Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care.

KEY SECONDARY OBJECTIVES:

To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a centralized, blinded provider assessment review of photographs.

II. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a non-blinded institutional provider assessment.

III. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a combined patient and non-blinded institutional provider assessment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care skin management during radiation therapy for up to 6 weeks.

ARM II: Patients receive Mepitel Film applied to breast or chest wall as needed or once every 2 weeks before radiation therapy for up to 6 weeks.

After completion of study, patients are followed up at 7-14 days, 3 months, 6 months, 1 year, 2 years, then every 6 months up to 5 years.

Conditions: Breast Carcinoma
Being tested: Best Practice, Wound Dressing Material, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called Standard of Care
Receive standard of care
Wound Dressing MaterialDevice
Apply Mepitel Film
Quality-of-Life AssessmentOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT04989504
Study group	Role	What they receive
Arm I (standard of care)	Active comparator	Patients receive standard of care skin management during radiation therapy for up to 6 weeks. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (Mepitel Film)	Experimental	Patients receive Mepitel Film applied to breast or chest wall every 2 weeks before radiation therapy for up to 6 weeks. Receives: Device: Wound Dressing Material; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a patient-completed mRISRAS score ranges from 0 to 12, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Measured: Up to 5 months

Secondary outcomes (3)

Centralized, Blinded Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores Obtained From a Blinded Grading of the Photographs Taken at the End of Radiation Therapy
At the completion of radiation therapy, photographs will be obtained one hour after the removal of the Mepitel Film or immediately following completion of radiation therapy for patients on the standard of care arm. A panel of radiation oncology providers will perform the blinded, central review to score the photographs. Each provider will independently assign a provider-completed mRISRAS score to each photograph, and the average score will be calculated for each patient. The provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The Wilcoxon rank-sum test will be used to test for an effect of the Mepitel Film.
Measured: Up to 2 months
Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Measured: Up to 5 months
Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 36, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Measured: Up to 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 202215 Feb 2029

First posted4 Aug 2021
Study start26 Jul 2022
Primary completion29 May 2024
Study completion15 Feb 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CarcinomaStudies of the same condition, open and under way.
More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04989504
Sponsor's protocol ID: A221803
Other IDs: NCI-2019-04688, UG1CA189823
Status last verified: Aug 2026
First submitted: 26 Jul 2021
Last updated: 23 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial
ClinicalTrials.gov ID: NCT04989504
Acronym / sponsor ID: A221803
Conditions: Breast Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 216 participants (actual)
Lead sponsor: Alliance for Clinical Trials in OncologyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 26 Jul 2022 (actual)
Primary completion: 29 May 2024 (actual)
Study completion: 15 Feb 2029 (estimated)
First posted: 4 Aug 2021 (actual)
Results: Posted 29 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care.

KEY SECONDARY OBJECTIVES:

To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a centralized, blinded provider assessment review of photographs.

II. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a non-blinded institutional provider assessment.

III. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a combined patient and non-blinded institutional provider assessment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care skin management during radiation therapy for up to 6 weeks.

ARM II: Patients receive Mepitel Film applied to breast or chest wall as needed or once every 2 weeks before radiation therapy for up to 6 weeks.

After completion of study, patients are followed up at 7-14 days, 3 months, 6 months, 1 year, 2 years, then every 6 months up to 5 years.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm I (standard of care)	Active comparator	Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive standard of care skin management during radiation therapy for up to 6 weeks.
Arm II (Mepitel Film)	Experimental	Device: Wound Dressing Material, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive Mepitel Film applied to breast or chest wall every 2 weeks before radiation therapy for up to 6 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Histologic confirmation of breast malignancy with TNM staging.
Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy.
No prior radiotherapy to any portion of the planned treatment site.
No documented history of adhesive or tape allergy.
Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible.

Key exclusion criteria (0 listed)

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
Best PracticeAlso: Standard of CareReceive standard of care	Other	Arm I (standard of care)
Wound Dressing MaterialApply Mepitel Film	Device	Arm II (Mepitel Film)
Quality-of-Life AssessmentAncillary studies	Other	Arm I (standard of care), Arm II (Mepitel Film)
Questionnaire AdministrationAncillary studies	Other	Arm I (standard of care), Arm II (Mepitel Film)

Primary outcome

Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Time frame: Up to 5 months
Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a patient-completed mRISRAS score ranges from 0 to 12, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.

3 secondary outcomes

Centralized, Blinded Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores Obtained From a Blinded Grading of the Photographs Taken at the End of Radiation Therapy
Time frame: Up to 2 months
Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Time frame: Up to 5 months
Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Time frame: Up to 5 months

Results and safety

Results posted to the registry on 29 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Standard of Care)	73	65
Arm II (Mepitel Film)	143	143

Primary outcome: Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores

Time frame: Up to 5 months. Median (95% Confidence Interval). Unit: score on a scale*month

Measure	Arm I (Standard of Care) n = 60	Arm II (Mepitel Film) n = 132
Value	46.24 (38.42 to 54.06)	35.32 (29.40 to 41.23)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Standard of Care)	2 of 65 (3.1%)	59 of 65 (90.8%)	0 of 65
Arm II (Mepitel Film)	7 of 143 (4.9%)	133 of 143 (93%)	0 of 143

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Breast Carcinoma

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
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A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Kimberly Corbin, MD study chair

Mayo Clinic

49 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores (time frame: Up to 5 months). 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 NCT04989504.

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 23 Sep 2026.