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: Completed
• Conditions: Breast Carcinoma
• Intervention / Treatment: Device: Evonail; Device: Placebo excipient

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre lès Nancy, France, 54519
    • Institut de cancérologie de Lorraine

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Collaborators: Clinact
• Investigators: Principal Investigator: UWER Lionel, MD, Institut de cancérologie de Lorraine

Study record dates

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: chemotherapy neoadjuvant
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2011-A00981-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO