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

Dario Valcarenghi

Status and phase: Completed; Phase 3

Conditions: Post-surgery Radiotherapy

Treatments: Drug: skin cream; Device: Mepitel Film

Study type: Interventional

Funder types: Other

Identifiers

NCT02741258

IOSI-INF-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Mepitel Film

Experimental group

Description:

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.

Treatment:

Device: Mepitel Film

Excipial U hydrolotion, Flammazin skin cream

Active Comparator group

Description:

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.

Treatment:

Drug: skin cream