Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer. (EVONAIL)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Breast Carcinoma

Treatments: Device: Placebo excipient; Device: Evonail

Study type: Interventional

Funder types: Other

Identifiers

NCT02870699

2011-A00981-40

Details and patient eligibility

About

Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.

Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.

The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• Patient with breast carcinoma
• Patients treated with adjuvant chemotherapy (FEC + 3 docetaxel +/- Herceptin®)
• Patients who have never been treated with taxanes
• Patients with no nail damage before starting the study
• ECOG performance < 2
• Ability to provide written informed consent

Exclusion criteria

• Patient allergic to any of the treatment components
• Use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment
• Risk of exposure to aggressive factors nail during the study
• Using refrigerants gloves during chemotherapy treatments
• Onychophagia
• Presence of nail disease or a history of nail pathology (infectious and other)
• Pregnant or breast feeding females
• Patients whose condition is not compatible with the follow-up study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

ARM A

Experimental group

Description:

* Evonail film forming solution : 1 daily application on the left hand * Placebo excipient : 1 daily application on the right hand

Treatment:

Device: Evonail

Device: Placebo excipient

ARM B

Active Comparator group

Description:

* Evonail film forming solution : 1 daily application on the right hand * Placebo excipient : 1 daily application on the left hand

Treatment:

Device: Evonail

Device: Placebo excipient