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Completed

NCT Number: NCT02870699

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evonail

Device

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

Placebo excipient

Device

film forming excipient solution

Primary outcomes

  1. Efficacy of the film-forming solution Evonail® versus placebo on nail damage

    Time frame: up to 9 weeks

    Efficacy will be evaluated by the oncologist according to NCI-CTC

Secondary outcomes

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

    Time frame: up to 9 weeks

    Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC

  2. Patient compliance for the film-forming solution Evonail®

    Time frame: up to 9 weeks

    Patient compliance will be evaluated using a questionnaire

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

    Time frame: up to 9 weeks

    Patient satisfaction will be evaluated using a questionnaire

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Collaborators

  • Clinact

Registry information

Official study 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.

Acronym: EVONAIL

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 17, 2016
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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