A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis
A Prospective Randomized Controlled Trial of Evonail® Solution for Prevention or Treatment of Onycholysis in Breast Cancer Patients Who Received Neoadjuvant/Adjuvant Docetaxel Chemotherapy
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Aug 2015
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedApril 28, 2017
April 1, 2017
10 months
January 28, 2016
April 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of onycholysis Gr 2 or more
12weeks
Study Arms (2)
Experimental arm
EXPERIMENTALIn experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more.
Control arm
OTHERIn 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy
You may not qualify if:
- Patients with breast cancer receiving palliative docetaxel chemotherapy
- Patients having onycholysis before docetaxel treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
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.
PMID: 28488142DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- This study is open-labeled study. But outcome would be assessed the statistician who did not involve this study with blind data.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,Ph.D
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 2, 2016
Study Start
August 1, 2015
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
April 28, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share