Clinical trial · Interventional
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial
NCT04989504CI-TRIAL-00089054active not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Wound Dressing Material | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (standard of care)
- description
- Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
- interventionNames
- Other: Best Practice
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (Mepitel Film)
- description
- Patients receive Mepitel Film applied to breast or chest wall every 2 weeks before radiation therapy for up to 6 weeks.
- interventionNames
- Device: Wound Dressing Material
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.