Back to resultsEffect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib
Primary Purpose
Paronychia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
zanthoxylum nitidum tincture
tetracycline ointment
Sponsored by
About this trial
This is an interventional treatment trial for Paronychia focused on measuring Paronychia, Zanthoxylum nitidum tincture, Afatinib
Eligibility Criteria
Inclusion Criteria:
- Pathologically or cytologically confirmed non-small cell lung cancer；
- Undergoing treatment with afatinib；
- With grade 1 paronychia；
- Age between 18 to 80 years old；
- Estimated life expectancy of more than months；
- With the written informed consent.
Exclusion Criteria:
- Paronychia before afatinib treatment;
- Grade 2 or severer paronychia;
- Stop using afatinib or with reduced dose of afatinib;
- Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.
- Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.
Sites / Locations
- Guangdong Provincial Hospital of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combination group
Control group
Arm Description
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, plus local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day, till paronychia relief or progression.
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression.
Outcomes
Primary Outcome Measures
Paronychia progress rate
Incidence of grade 2 or more paronychia during paronychia treatment period will be reported. This period will be from randomization till paronychia relief or progression. Frequency of evaluation for paronychia will be everyday.
Secondary Outcome Measures
Time to paronychia progress
The time elapsed from randomization to either the date of grade 2 or more paronychia occurrence, treatment completion, or last follow-up information. Frequency of evaluation for paronychia will be everyday.
Time to paronychia relief
The time elapsed from randomization to either the date of paronychia relief, treatment completion, or last follow-up information. Paronychia relief is defined as that paronychia disappears. Frequency of evaluation for paronychia will be everyday.
Full Information
NCT ID
NCT03908892
First Posted
February 21, 2019
Last Updated
August 11, 2022
Sponsor
Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03908892
Brief Title
Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib
Official Title
A Clinical Study on the Treatment of Paronychia Caused by Afatinib With Zanthoxylum Nitidum Tincture
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized control trial evaluating the efficacy of zanthoxylum nitidum tincture on preventing progression of paronychia caused by afatinib from grade 1 to grade 2/3. Enrolled participates will randomly receive original treatment or original treatment plus zanthoxylum nitidum tincture immersion of the sick nail(s).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paronychia
Keywords
Paronychia, Zanthoxylum nitidum tincture, Afatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combination group
Arm Type
Experimental
Arm Description
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, plus local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day, till paronychia relief or progression.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression.
Intervention Type
Drug
Intervention Name(s)
zanthoxylum nitidum tincture
Intervention Description
Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.
Intervention Type
Drug
Intervention Name(s)
tetracycline ointment
Intervention Description
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day
Primary Outcome Measure Information:
Title
Paronychia progress rate
Description
Incidence of grade 2 or more paronychia during paronychia treatment period will be reported. This period will be from randomization till paronychia relief or progression. Frequency of evaluation for paronychia will be everyday.
Time Frame
Through study completion, an average of 10 days.
Secondary Outcome Measure Information:
Title
Time to paronychia progress
Description
The time elapsed from randomization to either the date of grade 2 or more paronychia occurrence, treatment completion, or last follow-up information. Frequency of evaluation for paronychia will be everyday.
Time Frame
Through study completion, an average of 10 days.
Title
Time to paronychia relief
Description
The time elapsed from randomization to either the date of paronychia relief, treatment completion, or last follow-up information. Paronychia relief is defined as that paronychia disappears. Frequency of evaluation for paronychia will be everyday.
Time Frame
Through study completion, an average of 10 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically or cytologically confirmed non-small cell lung cancer；
Undergoing treatment with afatinib；
With grade 1 paronychia；
Age between 18 to 80 years old；
Estimated life expectancy of more than months；
With the written informed consent.
Exclusion Criteria:
Paronychia before afatinib treatment;
Grade 2 or severer paronychia;
Stop using afatinib or with reduced dose of afatinib;
Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.
Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanjuan Zhu, Dr
Phone
86 20 81887233
Ext
34830
Email
zyjsophy@gzucm.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yihong Liu, Dr
Phone
80 20 81887233
Ext
34830
Email
yihongl@gzucm.edu.cn
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanjuan Zhu, Dr.
Phone
86 20 81887233
Ext
34830
Email
zyjsophy@gzucm.edu.cn
First Name & Middle Initial & Last Name & Degree
Yihong Liu, Dr.
Phone
86 20 81887233
Ext
34830
Email
yihongl@gzucm.edu.cn
First Name & Middle Initial & Last Name & Degree
Haibo Zhang, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib
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