Post-surgery Radiotherapy Clinical Trial
Official title:
Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer
Verified date | June 2022 |
Source | Oncology Institute of Southern Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 164 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 - previous breast radiation treatment - participating in other clinical trials - previous breast reconstruction - concomitant treatment with antiblastic chemotherapy |
Country | Name | City | State |
---|---|---|---|
Switzerland | Oncology Institute of Southern Switzerland | Bellinzona | |
Switzerland | Institut für Radiotherapie Klinik Hirslanden | Zürich |
Lead Sponsor | Collaborator |
---|---|
Dario Valcarenghi |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE) | Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity | one week after start of radiotherapy | |
Secondary | Time for the skin toxicity appearance and resolution | one week after start of radiotherapy | ||
Secondary | Severity of the chronic skin toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v.4 | one week after start of radiotherapy |