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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Post-surgery Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mepitel Film

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.

Group Type EXPERIMENTAL

Mepitel Film

Intervention Type DEVICE

Placement of Mepitel Film to prevent skin toxicity

Excipial U hydrolotion, Flammazin skin cream

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.

Group Type ACTIVE_COMPARATOR

skin cream

Intervention Type DRUG

cream to treat skin erythema due to radiotherapy

Interventions

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Mepitel Film

Placement of Mepitel Film to prevent skin toxicity

Intervention Type DEVICE

skin cream

cream to treat skin erythema due to radiotherapy

Intervention Type DRUG

Other Intervention Names

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Excipial U hydrolotion, Flammazin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No