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NCT Number: NCT02741258

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

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.

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Key information

Conditions

Post-surgery Radiotherapy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Oncology Institute of Southern Switzerland, Bellinzona, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepitel Film

Device

Placement of Mepitel Film to prevent skin toxicity

skin cream

Drug

cream to treat skin erythema due to radiotherapy

Other names: Excipial U hydrolotion, Flammazin

Primary outcomes

  1. Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: one week after start of radiotherapy

    Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity

Secondary outcomes

  1. Time for the skin toxicity appearance and resolution

    Time frame: one week after start of radiotherapy

  2. Severity of the chronic skin toxicity

    Time frame: one week after start of radiotherapy

    Common Terminology Criteria for Adverse Events (CTCAE) v.4

Sponsors and collaborators

Lead sponsor

Dario Valcarenghi

Other

Registry information

Official study title

Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2016
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.