Breast CancerNCT07729423
Mepitel Film Breast
An observational study of Breast Cancer and Radiation Dermatitis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Nov 2025to 30 Jun 2029
- Phase
- Observational
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: National University Hospital
Who may be able to join
- Age ≥ 21 years old (legal age of maturity in Singapore)
- Male or female
- Informed consent
- Patients have undergone a mastectomy with or without reconstruction or breast-conserving surgery.
- Histological confirmation of breast carcinoma (invasive or in situ carcinoma)
- Patients are scheduled to receive hypofractionated (40Gy in 15 daily fractions or 26Gy in 5 daily fractions) photon-based RT
- Patient treated with or without tissue the addition of equivalent bolus and/or boost.
- Can communicate in English or be aided by a translator.
Who cannot join
- Prior RT to any portion of the planned treatment site.
- Patients will receive partial breast external beam RT, proton beam therapy, or brachytherapy.
- Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area may make skin assessment for the study difficult per treating physician discretion.
- Known history of adhesive, tape or silicon allergy or sensitivity.
- Concomitant cytotoxic chemotherapy
- Bilateral breast pathology requiring concurrent bilateral breast or chest wall RT.
- Current inflammatory breast cancer or gross dermal involvement at initiation of RT.
- Patient has a Karnofsky Performance Status score <60.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Qian Yee Chai, BSc, +6567723077, queenie_qy_chai@nuhs.edu.sg
Fatin Aliyah Binte Hussin, BSc, +6567723079, Fatin_HUSSIN@nuhs.edu.sg
About this study
Official title: The Tolerability of Mepitel Film for the Prevention of Radiation Dermatitis in Breast Cancer Patients in Hot Weather: A Feasibility Study
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore
Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel Film use.
Read the detailed description
This prospective, observational feasibility study will enroll 60 breast cancer patients, divided into two cohorts: 30 receiving local breast RT and 30 receiving chest wall RT post-mastectomy. We hypothesize that Mepitel Film will be well-tolerated and effective in preventing severe RD (Grade ≥2) in this population, with results compared to published data from Western countries. Previous randomized controlled trials (RCTs) conducted in regions with low humidity and cool temperatures have raised concerns about film adherence and cost in tropical climates. Therefore, assessing the efficacy of Mepitel Film in a hot and humid environment is warranted.
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- dermatitis, radiation dermatitis, breast cancer, Mepitel Film
- Medical subject headings
- Breast Neoplasms, Radiodermatitis, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast radiation | Not described | |
| Patients with chest wall radiation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada
Measured: From first day RT to the 2 weeks post RT
Secondary outcomes (12)
Frequency and severity of patient reported pruritis in SSA and RISRAS related to use of Mepitel Film when compared with the data from the RCT in Ontario, Canada
Measured: From enrollment to the 3 months post RT
Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP
Measured: From enrollment to the 2 weeks post RT
Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA)
Measured: From enrollment to the end of study (2 years post RT)
HCP reported SSA
Measured: From enrollment to the end of study (2 years post RT)
Incidence of moist desquamation assessed by HCP
Measured: From enrollment to 2 weeks post RT
Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient and HCP
Measured: From enrollment to 3 months post RT
Blinded HCP-assessed mRISRAS scores from blinded grading of photographs taken at the end of RT
Measured: End of RT treatment
Photographs with EORTC-BCRS
Measured: From enrollment to the end of study (2 years post RT)
Patient-reported QOL using the Skindex-16
Measured: From enrollment to the end of study (2 years post RT)
Patient satisfaction with Mepitel Film as assessed by the patient satisfaction questionnaire
Measured: 3 months post RT
HCP satisfaction with Mepitel Film as assessed by the HCP satisfaction questionnaire
Measured: 3 months post RT
Cost analysis of Mepitel Film for prevention of RD (evaluation and calculation of Mepitel Film usage and financial cost using Film Integrity Assessment)
Measured: From first day RT to the 2 weeks post RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start12 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Molnlycke Health Care AB
- Responsible party
- Sponsor
- Investigators
- Wee Yao Koh, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729423
- Sponsor's protocol ID
- 2024-4228
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tolerability of Mepitel Film for the Prevention of Radiation Dermatitis in Breast Cancer Patients in Hot Weather: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07729423
- Acronym / sponsor ID
- 2024-4228
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- dermatitis, radiation dermatitis, breast cancer, Mepitel Film
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Molnlycke Health Care AB
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 27 Jul 2026 (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.
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore
Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel Film use.
Detailed description
This prospective, observational feasibility study will enroll 60 breast cancer patients, divided into two cohorts: 30 receiving local breast RT and 30 receiving chest wall RT post-mastectomy. We hypothesize that Mepitel Film will be well-tolerated and effective in preventing severe RD (Grade ≥2) in this population, with results compared to published data from Western countries. Previous randomized controlled trials (RCTs) conducted in regions with low humidity and cool temperatures have raised concerns about film adherence and cost in tropical climates. Therefore, assessing the efficacy of Mepitel Film in a hot and humid environment is warranted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with breast radiation | – | – |
| Patients with chest wall radiation | – | – |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- National University Hospital
Key inclusion criteria (8 listed)
- Age ≥ 21 years old (legal age of maturity in Singapore)
- Male or female
- Informed consent
- Patients have undergone a mastectomy with or without reconstruction or breast-conserving surgery.
- Histological confirmation of breast carcinoma (invasive or in situ carcinoma)
Key exclusion criteria (8 listed)
- Prior RT to any portion of the planned treatment site.
- Patients will receive partial breast external beam RT, proton beam therapy, or brachytherapy.
- Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area may make skin assessment for the study difficult per treating physician discretion.
- Known 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.
Primary outcome
Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada
Time frame: From first day RT to the 2 weeks post RT
12 secondary outcomes
Frequency and severity of patient reported pruritis in SSA and RISRAS related to use of Mepitel Film when compared with the data from the RCT in Ontario, Canada
Time frame: From enrollment to the 3 months post RT
Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP
Time frame: From enrollment to the 2 weeks post RT
Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA)
Time frame: From enrollment to the end of study (2 years post RT)
HCP reported SSA
Time frame: From enrollment to the end of study (2 years post RT)
Incidence of moist desquamation assessed by HCP
Time frame: From enrollment to 2 weeks post RT
Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient and HCP
Time frame: From enrollment to 3 months post RT
Blinded HCP-assessed mRISRAS scores from blinded grading of photographs taken at the end of RT
Time frame: End of RT treatment
Photographs with EORTC-BCRS
Time frame: From enrollment to the end of study (2 years post RT)
Patient-reported QOL using the Skindex-16
Time frame: From enrollment to the end of study (2 years post RT)
Patient satisfaction with Mepitel Film as assessed by the patient satisfaction questionnaire
Time frame: 3 months post RT
HCP satisfaction with Mepitel Film as assessed by the HCP satisfaction questionnaire
Time frame: 3 months post RT
Cost analysis of Mepitel Film for prevention of RD (evaluation and calculation of Mepitel Film usage and financial cost using Film Integrity Assessment)
Time frame: From first day RT to the 2 weeks post RT
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 27 Jul 2026.
- 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.
Wee Yao Koh, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiation Dermatitis, run by National University Hospital, Singapore at 1 site in Singapore.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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 Singapore. 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?
Contact Shing Fung Lee, MBBS (+6567726392, leesf@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada (time frame: From first day RT to the 2 weeks post RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.