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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741258
• Other study ID #: IOSI-INF-001
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Oncology Institute of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

For patients randomized in the mepitel arm:

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.

For patients randomized in the standard of treatment arm:

Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Post-surgery Radiotherapy

Intervention

Device:
• Mepitel Film
Placement of Mepitel Film to prevent skin toxicity

Drug:
• skin cream
cream to treat skin erythema due to radiotherapy

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona
Switzerland	Institut für Radiotherapie Klinik Hirslanden	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Dario Valcarenghi

Country where clinical trial is conducted

Switzerland, 

Outcome

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