- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02870699
Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer. (EVONAIL)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vandoeuvre lès Nancy, France, 54519
- Institut de Cancérologie de Lorraine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARM A
|
film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter
film forming excipient solution
|
Active Comparator: ARM B
|
film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter
film forming excipient solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of the film-forming solution Evonail® versus placebo on nail damage
Time Frame: up to 9 weeks
|
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
Time Frame: up to 9 weeks
|
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®
Time Frame: up to 9 weeks
|
Patient compliance will be evaluated using a questionnaire
|
up to 9 weeks
|
Patient satisfaction regarding the use of the film-forming solution Evonail®
Time Frame: up to 9 weeks
|
Patient satisfaction will be evaluated using a questionnaire
|
up to 9 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: UWER Lionel, MD, Institut de Cancérologie de Lorraine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A00981-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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