NCT02870699

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Institut de Cancérologie de Lorraine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-06-01
• Completion: 2016-06-01
• First posted: 2016-08-17
• Last updated: 2023-09-28

Locations

1 site across 1 country: France