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

Breast Carcinoma Clinical Trial

— EVONAIL  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870699
• Other study ID #: 2011-A00981-40
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: June 2016

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Device:
• Evonail
film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter
• Placebo excipient
film forming excipient solution

Locations

Country	Name	City	State
France	Institut de Cancerologie de Lorraine	Vandoeuvre lès Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine	Clinact

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient compliance for the film-forming solution Evonail®	Patient compliance will be evaluated using a questionnaire	up to 9 weeks
Secondary	Patient satisfaction regarding the use of the film-forming solution Evonail®	Patient satisfaction will be evaluated using a questionnaire	up to 9 weeks