Breast CancerNCT02670603
A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis
A study testing EVONAIL® solution in people with Breast Cancer and Docetaxel Chemotherapy, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Docetaxel Chemotherapy
- What is being tested?
- EVONAIL® solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy
Who cannot join
- Patients with breast cancer receiving palliative docetaxel chemotherapy
- Patients having onycholysis before docetaxel treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Breast Cancer, Docetaxel Chemotherapy
- Being tested
- EVONAIL® solution
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVONAIL® solutionDrug
Also called Hydrating Nail Solution
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | In experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more. Receives: Drug: EVONAIL® solution |
| Control arm | Other | 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. Receives: Drug: EVONAIL® solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of onycholysis Gr 2 or more
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670603
- Sponsor's protocol ID
- 2015-04-018-002
- Status last verified
- Apr 2017
- First submitted
- 28 Jan 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28488142
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02670603
- Acronym / sponsor ID
- 2015-04-018-002
- Conditions
- Breast Cancer, Docetaxel Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: EVONAIL® solutionIn experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more. |
| Control arm | Other | Drug: EVONAIL® solutionIn 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy
Key exclusion criteria (2 listed)
- Patients with breast cancer receiving palliative docetaxel chemotherapy
- Patients having onycholysis before docetaxel treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVONAIL® solutionAlso: Hydrating Nail Solution | Drug | Control arm, Experimental arm |
Primary outcome
The incidence of onycholysis Gr 2 or more
Time frame: 12weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 28488142Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVONAIL® solution in people with Breast Cancer and Docetaxel Chemotherapy, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of onycholysis Gr 2 or more (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.