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Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

StatusActive, Not Recruiting
PhasePhase 3
Started2022-07-26
View on ClinicalTrials.gov ↗

Amendment history

2025-04-23
Study Status, Outcome Measures (Results) v11
Results first postednot stated→2025-04-29
2025-03-31
Study Identification, Study Status, Oversight, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v10
Secondary endpoints3 entries, revised
Centralized, blindedBlinded providerProvider-completed modifiedModified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scoresScores obtainedObtained fromFrom a blindedBlinded gradingGrading of the photographsPhotographs takenTaken at the endEnd of radiationRadiation therapyTherapy Serially measuredMeasured nonNon-blinded institutionalInstitutional providerProvider-completed modifiedModified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scoresScores Serially measuredMeasured combinedCombined patientPatient- and providerProvider-completed modifiedModified Radiation Induc [...] [...]
Primary endpoints1 entry, revised
Serially measuredMeasured patientPatient-completed modifiedModified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scoresScores
2025-01-15
Study Identification, Study Status, Oversight v9
Re-verified, no change to tracked fields
2024-07-01
Study Status v8
Primary completion dateestimated 2025-12-31→confirmed 2024-05-29
Completion date2025-12-31→2029-02-15
2024-04-08
Study Status v7
Start date2022-06-15→2022-07-26
Show 6 earlier versions
2024-02-19
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 49 of 49 sites
2023-10-30
Study Status, Contacts/Locations v5
Study sites46→49
2023-04-03
Study Status, Contacts/Locations v4
Study sites11→46
2022-08-02
Study Status, Contacts/Locations v3
Study sites3→11
2022-07-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-10→confirmed 2022-06-15
Study sites0→3
2021-08-27
Study Status v1
Completion date2028-12-31→2025-12-31
2021-07-26
Original filing
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.
Trial Details
NCT Number NCT04989504
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Breast Carcinoma
Enrollment 216 participants
Start Date 2022-07-26
Primary Completion 2024-05-29 (estimated)
Study Completion 2029-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-23