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

Primary Purpose

Breast Carcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evonail
Placebo excipient
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma focused on measuring chemotherapy neoadjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancerologie de Lorraine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARM A

ARM B

Arm Description

Evonail film forming solution : 1 daily application on the left hand Placebo excipient : 1 daily application on the right hand

Evonail film forming solution : 1 daily application on the right hand Placebo excipient : 1 daily application on the left hand

Outcomes

Primary Outcome Measures

Efficacy of the film-forming solution Evonail® versus placebo on nail damage
Efficacy will be evaluated by the oncologist according to NCI-CTC

Secondary Outcome Measures

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
Patient compliance for the film-forming solution Evonail®
Patient compliance will be evaluated using a questionnaire
Patient satisfaction regarding the use of the film-forming solution Evonail®
Patient satisfaction will be evaluated using a questionnaire

Full Information

First Posted
August 12, 2016
Last Updated
September 26, 2023
Sponsor
Institut de Cancérologie de Lorraine
Collaborators
Clinact
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1. Study Identification

Unique Protocol Identification Number
NCT02870699
Brief Title
Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine
Collaborators
Clinact

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma
Keywords
chemotherapy neoadjuvant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM A
Arm Type
Experimental
Arm Description
Evonail film forming solution : 1 daily application on the left hand Placebo excipient : 1 daily application on the right hand
Arm Title
ARM B
Arm Type
Active Comparator
Arm Description
Evonail film forming solution : 1 daily application on the right hand Placebo excipient : 1 daily application on the left hand
Intervention Type
Device
Intervention Name(s)
Evonail
Intervention Description
film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter
Intervention Type
Device
Intervention Name(s)
Placebo excipient
Intervention Description
film forming excipient solution
Primary Outcome Measure Information:
Title
Efficacy of the film-forming solution Evonail® versus placebo on nail damage
Description
Efficacy will be evaluated by the oncologist according to NCI-CTC
Time Frame
up to 9 weeks
Secondary Outcome Measure Information:
Title
Different types of nail damage observed in each group after chemotherapy docetaxel
Description
Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC
Time Frame
up to 9 weeks
Title
Patient compliance for the film-forming solution Evonail®
Description
Patient compliance will be evaluated using a questionnaire
Time Frame
up to 9 weeks
Title
Patient satisfaction regarding the use of the film-forming solution Evonail®
Description
Patient satisfaction will be evaluated using a questionnaire
Time Frame
up to 9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UWER Lionel, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de Lorraine
City
Vandoeuvre lès Nancy
ZIP/Postal Code
54519
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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