Breast Carcinoma Clinical Trial
— EVONAILOfficial 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.
NCT number | NCT02870699 |
Other study ID # | 2011-A00981-40 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | June 2016 |
Verified date | August 2018 |
Source | Institut de Cancérologie de Lorraine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut de Cancerologie de Lorraine | Vandoeuvre lès Nancy |
Lead Sponsor | Collaborator |
---|---|
Institut de Cancérologie de Lorraine | Clinact |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Different types of nail damage observed in each group after chemotherapy docetaxel | Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC | up to 9 weeks | |
Secondary | Patient compliance for the film-forming solution Evonail® | Patient compliance will be evaluated using a questionnaire | up to 9 weeks | |
Secondary | Patient satisfaction regarding the use of the film-forming solution Evonail® | Patient satisfaction will be evaluated using a questionnaire | up to 9 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04996316 -
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
|
||
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT05526872 -
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
|
N/A | |
Not yet recruiting |
NCT05178498 -
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
|
||
Recruiting |
NCT05544123 -
The Treatment Situation of Chinese County Population With Breast Cancer
|
||
Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
Completed |
NCT01422408 -
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
|
Phase 2 | |
Terminated |
NCT00770354 -
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
|
Phase 2 | |
Terminated |
NCT02810873 -
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
|
N/A | |
Withdrawn |
NCT03185871 -
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
|
Phase 2 | |
Completed |
NCT02983279 -
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
|
N/A | |
Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
Recruiting |
NCT05406232 -
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
|
||
Recruiting |
NCT03408353 -
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
|
||
Completed |
NCT01641068 -
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
|
N/A | |
Withdrawn |
NCT04190433 -
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
|
Phase 2 | |
Recruiting |
NCT04799535 -
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
|
||
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |