Back to resultsA Trial of Evonail® Solution for Prevention or Treatment of Onycholysis
Primary Purpose
Breast Cancer, Docetaxel Chemotherapy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EVONAIL® solution
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy
Exclusion Criteria:
- Patients with breast cancer receiving palliative docetaxel chemotherapy
- Patients having onycholysis before docetaxel treatment
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental arm
Control arm
Arm Description
In experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more.
In control arm, each patient painted EVONAIL® solution on nails and periungual area twice a day after developing onycholysis grade 2. This study design allowed cross-over. Therefore, this control arm would give EVONAIL® solution after developing onlycholysis grade 2 in spite of control arm.
Outcomes
Primary Outcome Measures
The incidence of onycholysis Gr 2 or more
Secondary Outcome Measures
Full Information
NCT ID
NCT02670603
First Posted
January 28, 2016
Last Updated
April 26, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02670603
Brief Title
A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis
Official Title
A Prospective Randomized Controlled Trial of Evonail® Solution for Prevention or Treatment of Onycholysis in Breast Cancer Patients Who Received Neoadjuvant/Adjuvant Docetaxel Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a prospective randomized controlled study of EVONAIL® solution for prevention or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Docetaxel Chemotherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
This study is open-labeled study. But outcome would be assessed the statistician who did not involve this study with blind data.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
In experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more.
Arm Title
Control arm
Arm Type
Other
Arm Description
In control arm, each patient painted EVONAIL® solution on nails and periungual area twice a day after developing onycholysis grade 2.
This study design allowed cross-over. Therefore, this control arm would give EVONAIL® solution after developing onlycholysis grade 2 in spite of control arm.
Intervention Type
Drug
Intervention Name(s)
EVONAIL® solution
Other Intervention Name(s)
Hydrating Nail Solution
Primary Outcome Measure Information:
Title
The incidence of onycholysis Gr 2 or more
Time Frame
12weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy
Exclusion Criteria:
Patients with breast cancer receiving palliative docetaxel chemotherapy
Patients having onycholysis before docetaxel treatment
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28488142
Citation
Kim JY, Ok ON, Seo JJ, Lee SH, Ahn JS, Im YH, Park YH. A prospective randomized controlled trial of hydrating nail solution for prevention or treatment of onycholysis in breast cancer patients who received neoadjuvant/adjuvant docetaxel chemotherapy. Breast Cancer Res Treat. 2017 Aug;164(3):617-625. doi: 10.1007/s10549-017-4268-7. Epub 2017 May 9.
Results Reference
derived
Learn more about this trial
A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis
We'll reach out to this number within 24 hrs