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NCT02741258

Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy

Completed Phase 3 Last updated 5 July 2022
What this trial tests

Phase 3 trial testing Mepitel Film in Post-surgery Radiotherapy in 164 participants. Completed in 31 December 2021.

Timeline
1 October 2015
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorDario Valcarenghi
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment164
Start date1 October 2015
Primary completion31 December 2021
Estimated completion31 December 2021
Sites2 locations across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Dario Valcarenghi — full company profile →

Who can join

18 and older, female only, with Post-surgery Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer. Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mepitel® film versus standard care for the prevention of skin toxicity in breast cancer patients treated with adjuvant radiotherapy: A randomized controlled trial.
    Valcarenghi D, Tolotti A, Vees H, Torri V, et al · · 2025 · cited 1× · PMID 40110362 · DOI 10.1016/j.ctro.2025.100936

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