Clinical trial · Interventional
Patient Reported Outcomes Using Mepitel Film During Radiotherapy
Patient-reported Experience and Symptom Measures on Prophylactic Use of Mepitel Film During Post-operative Breast Irradiation - a Danish Intra-patient Randomized Multicentre Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer patients in post-operative radiotherapy (RT) often experience acute skin reactions like erythema, pain, itching and oversensitivity. In 2014 a New Zealand randomized controlled trial (RCT) investigated the prophylactic use of safetac-based film, Mepitel Film, on half of the breast during RT compared to cream, resulting in significant differences in skin moist desquamation (0% vs. 26%). Despite changes in treatment modalities in Denmark toward lower total RT doses, the level of RT-induced skin toxicity could still be of great importance for the patients. The aim of this study is patient-reported symptoms and patient-reported experiences with the prophylactic use of Mepitel Film compared to standard cream treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiodermatitis | — | UNRESOLVED | — |
| Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mepitel Film | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention side - Mepitel Film
- description
- This was an intra-patient randomized study. The patient was randomized for Mepitel film (barrier film) applied on the medial or lateral side of their breast or chest wall during the entire course of radiotherapy; making the patients their own control.
- interventionNames
- Other: Mepitel Film
- type
- NO_INTERVENTION
- label
- Control side - standard care
- description
- The other side of the breast or chest wall is the intra-patient control as the skin on this side was treated according to standard guidelines for skin care during radiotherapy when symptoms or skin reactions occured.
Primary outcomes (2)
- measure
- Patient-reported experience measures (PREM)
- timeFrame
- Two-week follow-up after RT
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 125 Years
Show eligibility criteria text
Inclusion Criteria: * All women referred to postoperative adjuvant radiotherapy for breast cancer from October 1st 2015 to February 29th 2016 at the three radiotherapy departments. * Who read and understand Danish * Patients must have signed and dated a written informed consent form in accordance with regulatory and institutional guidelines. * Patients must be willing and able to comply the questionnaires and attend a two-week follow-up posttreatment. Exclusion Criteria: * Patients included in the ongoing Danish HYPO PBI protocol (hypofractionated partial breast irradiation)
References
Publications (0)
Data not yet available