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

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Device: Evonail
* Device: Placebo excipient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A<br>Evonail film forming solution : 1 daily application on the left hand Placebo excipient : 1 daily application on the right hand | Device: Evonail<br>* film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter<br>Device: Placebo excipient<br>* film forming excipient solution<br>|
| Active Comparator: ARM B<br>Evonail film forming solution : 1 daily application on the right hand Placebo excipient : 1 daily application on the left hand | Device: Evonail<br>* film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter<br>Device: Placebo excipient<br>* film forming excipient solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the film-forming solution Evonail® versus placebo on nail damage | Efficacy will be evaluated by the oncologist according to NCI-CTC | up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different types of nail damage observed in each group after chemotherapy docetaxel | Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC | up to 9 weeks | 
| Patient compliance for the film-forming solution Evonail® | Patient compliance will be evaluated using a questionnaire | up to 9 weeks | 
| Patient satisfaction regarding the use of the film-forming solution Evonail® | Patient satisfaction will be evaluated using a questionnaire | up to 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy neoadjuvant