Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer. (EVONAIL)
September 26, 2023 updated by: Institut de Cancérologie de Lorraine
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vandoeuvre lès Nancy, France, 54519
- Institut de cancerologie de Lorraine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: UWER Lionel, MD, Institut de cancerologie de Lorraine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
August 12, 2016
First Submitted That Met QC Criteria
August 12, 2016
First Posted (Estimated)
August 17, 2016
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
August 1, 2018
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)?
NO
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.