An observational study in Breast Cancer and Radiation Dermatitis, sponsored by National University Hospital, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by National University Hospital, Singapore · Observational
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 60 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
National University Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2028, 37 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 37 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
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National University Hospital, Singapore →