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

NCT ID: NCT02870699

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

ARM A

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

Group Type: EXPERIMENTAL

Evonail

Intervention Type: DEVICE

film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter

Placebo excipient

Intervention Type: DEVICE

film forming excipient solution

ARM B

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

Group Type: ACTIVE_COMPARATOR

Evonail

Intervention Type: DEVICE

film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter

Placebo excipient

Intervention Type: DEVICE

film forming excipient solution

Interventions

Evonail

film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter

Intervention Type: DEVICE

Placebo excipient

film forming excipient solution

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinact

OTHER

Sponsor Role: collaborator

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UWER Lionel, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2011-A00981-40

Identifier Type: -

Identifier Source: org_study_id