Breast CancerNCT04166799
Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients
A study testing Mepitel Film in people with Breast Cancer and Radiation Dermatitis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- 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
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Male or female.
- Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes.
- Patients have undergone a mastectomy with or without reconstruction.
- Patients with large breasts [bra size 36 in and/or C cup or greater] and have undergone breast-conserving surgery.
- Patients are scheduled to receive conventionally- (50Gy/25#) or hypo-fractionated (42.56Gy/16#) photon-based radiation.
- Patients treated with or without the addition of tissue equivalent bolus or boost.
Who cannot join
- Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation.
- Prior radiotherapy to any portion of the planned treatment site.
- Active rash or pre-existing dermatitis within the treatment field.
- Known prior history of adhesive, tape or silicon allergy or sensitivity.
- Concomitant cytotoxic chemotherapy.
- Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy.
- Karnofsky Performance Status < 60.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: A Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment
Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. In response to the lack of evidence, Sunnybrook investigators previously conducted a pilot study (REB #294-2018) of Mepitel Film and preliminary results showed improvements in high grade skin reactions. Mepitel Film has not been widely adopted in North America as more evidence is needed. The validate the efficacy of the film compared to the standard of care, a study testing the efficacy of the film is proposed. In the study, 216 patients will be randomized (2:1) to receive either the film or the institution's current skin treatments and all patients will have their skin assessed.
Read the detailed description
Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin toxicities which adversely impact patients' quality of life. These skin toxicities may present in the form of acute reactions including erythema, pruritus or moist desquamation and late toxicities in the form of hyperpigmentation or fibrosis. The development of severe skin toxicities may result in treatment interruptions or increase the risk of reconstructive complications. Importantly, patients receiving radiotherapy to the chest wall or patients with larger breast size are more likely to have more severe skin reactions. In the last few decades, there have been no significant advances in preventing or treating radiation-induced skin toxicities.
A phase III randomized trial was conducted by Herst et al. (n=78) in New Zealand which showed that the prophylactic use of Mepitel Film prevented moist desquamation (26% vs. 0%, p < 0.001) and reduced skin reaction severity by 92% (p < 0.001) compared to skin treated only with aqueous cream. Mepitel Film has not been adopted in routine practice in North America as more convincing proof may be needed from international multi-centre trials to influence changes in standard clinical practice guidelines. A phase II feasibility study has recently been completed at Sunnybrook Odette Cancer Centre and the preliminary results have shown reductions in severe skin reactions.
Mayo Clinic has also completed a phase II pilot study which, like the feasibility study conducted at our centre, yielded promising results. The Alliance trial group in the US is planning for a phase III multi-centre trial for post-mastectomy patients receiving conventional radiation treatment. As the Alliance trial is only enrolling post-mastectomy patients receiving conventional radiotherapy, our study will additionally investigate outcomes for post-mastectomy patients receiving hypofractionated radiation treatment. Additionally, the investigators will be enrolling patients with large breasts [bra size 36 in and/or C cup or greater] as these patients are at known risk for developing increased acute skin toxicities
A randomized controlled trial is a critical next step in establishing whether Mepitel Film reduces acute and long-term skin toxicity in post-mastectomy and large breasted patients and in order for it to become standard of care in breast radiotherapy. This study plans to enroll 216 patients in a 2:1 ratio (2 Mepitel Film: 1 institutional standard of care).
The primary objective is to compare the efficacy of Mepitel Film versus the institutional standard of care in reducing the severity of radiation dermatitis in patients undergoing whole breast or chest wall radiotherapy. Secondary objectives include an evaluation of patient-reported and healthcare professional (HCP)-reported skin toxicities including moist desquamation with the use of Meptiel Film.
Radiation oncologists will first introduce the study to their patients in their breast clinic, showing a sample of the product and also pictures from the trial conducted in New Zealand. Patients if interested may be provided a patient information sheet to review at home. Then, patients will be approached by a CRA at their radiation planning appointment to review all information and obtain informed consent.
For patients randomized to the Mepitel Film arm, patients will receive the film for the entire duration of treatment. Radiation treatment will be delivered as prescribed by the treating radiation oncologist irrespective of study arm and may include a variety of techniques and beam modifiers.
- Conditions
- Breast Cancer, Radiation Dermatitis
- Being tested
- Mepitel Film
- Keywords
- Barrier Film, Mepitel, Quality of life, Radiation Dermatitis, Skin toxicity
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepitel FilmDevice
Mepitel® Film is a thin, soft and conformable transparent film dressing with Safetac®, offering protection for vulnerable skin.
| Study group | Role | What they receive |
|---|---|---|
| Mepitel Film Arm | Experimental | Patients randomized to the Mepitel Film arm will receive the film for the entire duration of their radiation treatment and will be worn up to 2 weeks after completion of radiotherapy. Receives: Device: Mepitel Film |
| Standard of Care Arm | No intervention | Patients randomized to the Standard of Care arm will be instructed to use the institutional standard of care skin treatments for the entire duration of their radiation treatment and up to 2 weeks after completion of radiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0.
Number of participants with radiation-induced skin toxicities as assessed by the Common Terminology Criteria for Adverse Events v.5.0, comparing changes in the treated versus non-treated breast or chest wall from baseline to weekly during radiation treatment and once a week for 6 weeks post-treatment.
Measured: Within 3 months following radiation
Secondary outcomes (5)
Number of participants with acute radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.
Number of participants with radiation-induced skin toxicities as assessed by a healthcare provider using the Common Terminology Criteria for Adverse Events v.5., change from baseline scores on a verbal rating scale compared to weekly assessments during radiation treatment and weekly for 6 weeks post-treatment. Subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling and trouble fitting brassieres graded as "none" (best), "mild", "moderate" or "severe" (worst).
Measured: Within 3 months following radiotherapy
Number of participants with acute radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.
Number of participants with radiation-induced skin toxicities as assessed by the participant using the Common Terminology Criteria for Adverse Events v.5., change from baseline scores on a verbal rating scale compared to weekly assessments during radiation treatment and weekly for 6 weeks post-treatment. Subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling and trouble fitting brassieres graded as "none" (best), "mild", "moderate" or "severe" (worst).
Measured: Within 3 months following radiotherapy
Number of participants with late radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.
Number of participants with radiation-induced skin toxicities as assessed by a healthcare provider using the Common Terminology Criteria for Adverse Events v.5., change from baseline scores on a verbal rating scale compared to weekly assessments during radiation treatment and weekly for 6 weeks post-treatment. Subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling and trouble fitting brassieres graded as "none" (best), "mild", "moderate" or "severe" (worst).
Measured: 6, 12 and 24 months following radiotherapy
Number of participants with late radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.
Number of participants with radiation-induced skin toxicities as assessed by the participant using the Common Terminology Criteria for Adverse Events v.5., change from baseline scores on a verbal rating scale compared to weekly assessments during radiation treatment and weekly for 6 weeks post-treatment. Subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling and trouble fitting brassieres graded as "none" (best), "mild", "moderate" or "severe" (worst).
Measured: 6, 12 and 24 months following radiotherapy
Number of participants with reconstruction complications as assessed by the BREAST-Q PROMS modules for breast-conserving therapy and reconstruction.
Number of participants with reconstruction complications as assessed by a clinician using the BREAST-Q PROMS for breast-conserving therapy and reconstruction to determine the efficacy of Mepitel Film in decreasing rates of reconstruction complications.
Measured: 12 and 24 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start30 Jan 2020
- Primary completion20 Aug 2024
- Study completionDec 2025 (estimated)
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.
- More trials run by Sunnybrook Health Sciences CentreThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients receiving chest wall radiation or patients with large breast size (bra size 36 in and/or C cup or greater) will be randomized 2:1 to receive either Mepitel Film or the institutional standard of care skin treatments.
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Edward Chow, Sunnybrook Health Sciences Centre
- Investigators
- Edward LW Chow, MBBS, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166799
- Sponsor's protocol ID
- Mepitel RCT
- Status last verified
- May 2025
- First submitted
- 13 Nov 2019
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Behroozian T, Milton L, Karam I, Zhang L, Ding K, Lou J, Gallant F, Rakovitch E, Tran W, Soliman H, Leung E, Vesprini D, Szumacher E, Chen H, Donovan E, Lam J, Spadafora S, Wronski M, Lavoie C, Walde N, Lam E, Wong G, McKenzie E, Ariello K, Kennedy S, Shariati S, Carothers K, Gonzales G, Kagan Y, Chow E. Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial. J Clin Oncol. 2023 Feb 20;41(6):1250-1264. doi: 10.1200/JCO.22.01873. Epub 2022 Dec 9.
PubMed 36493331
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment
- ClinicalTrials.gov ID
- NCT04166799
- Acronym / sponsor ID
- Mepitel RCT
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- Barrier Film, Mepitel, Quality of life, Radiation Dermatitis, Skin toxicity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 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.
Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. In response to the lack of evidence, Sunnybrook investigators previously conducted a pilot study (REB #294-2018) of Mepitel Film and preliminary results showed improvements in high grade skin reactions. Mepitel Film has not been widely adopted in North America as more evidence is needed. The validate the efficacy of the film compared to the standard of care, a study testing the efficacy of the film is proposed. In the study, 216 patients will be randomized (2:1) to receive either the film or the institution's current skin treatments and all patients will have their skin assessed.
Detailed description
Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin toxicities which adversely impact patients' quality of life. These skin toxicities may present in the form of acute reactions including erythema, pruritus or moist desquamation and late toxicities in the form of hyperpigmentation or fibrosis. The development of severe skin toxicities may result in treatment interruptions or increase the risk of reconstructive complications. Importantly, patients receiving radiotherapy to the chest wall or patients with larger breast size are more likely to have more severe skin reactions. In the last few decades, there have been no significant advances in preventing or treating radiation-induced skin toxicities.
A phase III randomized trial was conducted by Herst et al. (n=78) in New Zealand which showed that the prophylactic use of Mepitel Film prevented moist desquamation (26% vs. 0%, p < 0.001) and reduced skin reaction severity by 92% (p < 0.001) compared to skin treated only with aqueous cream. Mepitel Film has not been adopted in routine practice in North America as more convincing proof may be needed from international multi-centre trials to influence changes in standard clinical practice guidelines. A phase II feasibility study has recently been completed at Sunnybrook Odette Cancer Centre and the preliminary results have shown reductions in severe skin reactions.
Mayo Clinic has also completed a phase II pilot study which, like the feasibility study conducted at our centre, yielded promising results. The Alliance trial group in the US is planning for a phase III multi-centre trial for post-mastectomy patients receiving conventional radiation treatment. As the Alliance trial is only enrolling post-mastectomy patients receiving conventional radiotherapy, our study will additionally investigate outcomes for post-mastectomy patients receiving hypofractionated radiation treatment. Additionally, the investigators will be enrolling patients with large breasts [bra size 36 in and/or C cup or greater] as these patients are at known risk for developing increased acute skin toxicities
A randomized controlled trial is a critical next step in establishing whether Mepitel Film reduces acute and long-term skin toxicity in post-mastectomy and large breasted patients and in order for it to become standard of care in breast radiotherapy. This study plans to enroll 216 patients in a 2:1 ratio (2 Mepitel Film: 1 institutional standard of care).
The primary objective is to compare the efficacy of Mepitel Film versus the institutional standard of care in reducing the severity of radiation dermatitis in patients undergoing whole breast or chest wall radiotherapy. Secondary objectives include an evaluation of patient-reported and healthcare professional (HCP)-reported skin toxicities including moist desquamation with the use of Meptiel Film.
Radiation oncologists will first introduce the study to their patients in their breast clinic, showing a sample of the product and also pictures from the trial conducted in New Zealand. Patients if interested may be provided a patient information sheet to review at home. Then, patients will be approached by a CRA at their radiation planning appointment to review all information and obtain informed consent.
For patients randomized to the Mepitel Film arm, patients will receive the film for the entire duration of treatment. Radiation treatment will be delivered as prescribed by the treating radiation oncologist irrespective of study arm and may include a variety of techniques and beam modifiers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients receiving chest wall radiation or patients with large breast size (bra size 36 in and/or C cup or greater) will be randomized 2:1 to receive either Mepitel Film or the institutional standard of care skin treatments.
| Arm | Type | Receives |
|---|---|---|
| Mepitel Film Arm | Experimental | Device: Mepitel FilmPatients randomized to the Mepitel Film arm will receive the film for the entire duration of their radiation treatment and will be worn up to 2 weeks after completion of radiotherapy. |
| Standard of Care Arm | No intervention | –Patients randomized to the Standard of Care arm will be instructed to use the institutional standard of care skin treatments for the entire duration of their radiation treatment and up to 2 weeks after completion of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Male or female.
- Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes.
- Patients have undergone a mastectomy with or without reconstruction.
- Patients with large breasts [bra size 36 in and/or C cup or greater] and have undergone breast-conserving surgery.
Key exclusion criteria (7 listed)
- Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation.
- Prior radiotherapy to any portion of the planned treatment site.
- Active rash or pre-existing dermatitis within the treatment field.
- Known prior history of adhesive, tape or silicon allergy or sensitivity.
- Concomitant cytotoxic chemotherapy.
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 FilmMepitel® Film is a thin, soft and conformable transparent film dressing with Safetac®, offering protection for vulnerable skin. | Device | Mepitel Film Arm |
Primary outcome
Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0.
Time frame: Within 3 months following radiation
Number of participants with radiation-induced skin toxicities as assessed by the Common Terminology Criteria for Adverse Events v.5.0, comparing changes in the treated versus non-treated breast or chest wall from baseline to weekly during radiation treatment and once a week for 6 weeks post-treatment.
5 secondary outcomes
Number of participants with acute radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.
Time frame: Within 3 months following radiotherapy
Number of participants with acute radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.
Time frame: Within 3 months following radiotherapy
Number of participants with late radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.
Time frame: 6, 12 and 24 months following radiotherapy
Number of participants with late radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.
Time frame: 6, 12 and 24 months following radiotherapy
Number of participants with reconstruction complications as assessed by the BREAST-Q PROMS modules for breast-conserving therapy and reconstruction.
Time frame: 12 and 24 months post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 36493331Behroozian T, Milton L, Karam I, Zhang L, Ding K, Lou J, Gallant F, Rakovitch E, Tran W, Soliman H, Leung E, Vesprini D, Szumacher E, Chen H, Donovan E, Lam J, Spadafora S, Wronski M, Lavoie C, Walde N, Lam E, Wong G, McKenzie E, Ariello K, Kennedy S, Shariati S, Carothers K, Gonzales G, Kagan Y, Chow E. Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial. J Clin Oncol. 2023 Feb 20;41(6):1250-1264. doi: 10.1200/JCO.22.01873. Epub 2022 Dec 9.
- Individual participant dataSharing planned: No
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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.
Edward LW Chow, MBBS principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepitel Film in people with Breast Cancer and Radiation Dermatitis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 7 inclusion and 7 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0. (time frame: Within 3 months following radiation). 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 NCT04166799, 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 30 May 2025.