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

NCT02870699 | Completed

• 1 other identifier: 2011-A00981-40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

chemotherapy neoadjuvant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Different types of nail damage observed in each group after chemotherapy docetaxel

  up to 9 weeks

• Patient compliance for the film-forming solution Evonail®

  up to 9 weeks

• Patient satisfaction regarding the use of the film-forming solution Evonail®

  up to 9 weeks

Study Arms (2)

ARM A

EXPERIMENTAL

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

Device: Evonail; Device: Placebo excipient

ARM B

ACTIVE COMPARATOR

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

Device: Evonail; Device: Placebo excipient

Interventions

Evonail DEVICE

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

ARM A; ARM B

Placebo excipient DEVICE

film forming excipient solution

ARM A; ARM B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead
• Clinact: collaborator

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• UWER Lionel, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: September 28, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)