Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02741258 | Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy | PHASE3 | COMPLETED | 164 | — | — | Oct 1, 2015 | Dec 31, 2021 | Jul 5, 2022 | 2 | Switzerland |
Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity
| Arm | Type | Description |
|---|---|---|
| Mepitel Film | EXPERIMENTAL | Mepitel film will be placed on the patients' skin 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 the toxicities. In case of new skin toxicities appearance the patient will be retreated with Mepitel. |
| Excipial U hydrolotion, Flammazin skin cream | ACTIVE_COMPARATOR | Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine or Ialugen Plus) cream in case of skin erythema due to radiotherapy. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment. |
| Name | Type | Description |
|---|---|---|
| Mepitel Film | DEVICE | Placement of Mepitel Film to prevent skin toxicity |
| skin cream | DRUG | cream to treat skin erythema due to radiotherapy |
Inclusion Criteria: * patients with breast cancer treated with conservative surgery who need radiotherapy treatment * capability and willness to participate to the study * informed consent form signature Exclusion Criteria: * contraindication to the correct placement of the Mepitel Film * previou...