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

NCT02741258 | Completed Phase 3

• 1 other identifier: IOSI-INF-001
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Post-surgery Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time for the skin toxicity appearance and resolution

  one week after start of radiotherapy

• Severity of the chronic skin toxicity

  one week after start of radiotherapy

Study Arms (2)

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.

Device: Mepitel Film

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.

Drug: skin cream

Interventions

Mepitel Film DEVICE

Placement of Mepitel Film to prevent skin toxicity

Mepitel Film

skin cream DRUG

cream to treat skin erythema due to radiotherapy

Also known as: Excipial U hydrolotion, Flammazin

Excipial U hydrolotion, Flammazin skin cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with breast cancer treated with conservative surgery who need radiotherapy treatment
• capability and willness to participate to the study
• informed consent form signature

You may not qualify if:

• 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

Sponsors & Collaborators

• Dario Valcarenghi: lead

Study Sites (2)

Oncology Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

Location

Institut für Radiotherapie Klinik Hirslanden

Zurich, 8032, Switzerland

Location

MeSH Terms

Interventions

Skin Cream

Intervention Hierarchy (Ancestors)

Skin Care; Hygiene; Therapeutics; Cosmetics; Household Products; Technology, Industry, and Agriculture

Study Officials

• Dario Valcarenghi

  Oncology Institute of Southern Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Nurse

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 18, 2016
• Study Start: October 1, 2015
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)