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

Not Applicable

Completed

• Conditions: Breast Carcinoma
• Interventions: Device: Evonail; Device: Placebo excipient

• Registration Number: NCT02870699
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2015-06
• Study Completion: 2016-06
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Status Verified: 2018-08
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARM A	Placebo excipient	* Evonail film forming solution : 1 daily application on the left hand * Placebo excipient : 1 daily application on the right hand
ARM B	Placebo excipient	* Evonail film forming solution : 1 daily application on the right hand * Placebo excipient : 1 daily application on the left hand
ARM A	Evonail	* Evonail film forming solution : 1 daily application on the left hand * Placebo excipient : 1 daily application on the right hand
ARM B	Evonail	* Evonail film forming solution : 1 daily application on the right hand * Placebo excipient : 1 daily application on the left hand

Primary Outcome Measures

Name	Time	Method
Efficacy of the film-forming solution Evonail® versus placebo on nail damage	up to 9 weeks	Efficacy will be evaluated by the oncologist according to NCI-CTC

Secondary Outcome Measures

Name	Time	Method
Different types of nail damage observed in each group after chemotherapy docetaxel	up to 9 weeks	Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC
Patient satisfaction regarding the use of the film-forming solution Evonail®	up to 9 weeks	Patient satisfaction will be evaluated using a questionnaire
Patient compliance for the film-forming solution Evonail®	up to 9 weeks	Patient compliance will be evaluated using a questionnaire

Trial Locations

Locations (1)

Institut de Cancerologie de Lorraine; 🇫🇷 Vandoeuvre lès Nancy, France