Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643416
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Efficacy and Safety of Add-on Timolol for EGFR-TKI and ALK-TKI Induced Paronychia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Add-on Topical Timolol in the Management of Epidermal Growth Factor and Anaplastic Lymphoma Kinase Receptor Tyrosine Kinase Inhibitor-induced Paronychia a Prospective Randomized Open-labelled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the clinical efficacy of add-on topical timolol 05 eye drops to betamethasone valerate 01 for the treatment of EGFR-TKI and ALK-TKI induced paronychia
Detailed Description:
Lung cancer is the second leading cause of cancer and the leading cause of cancer-related death in Hong Kong Non-small cell lung cancer NSCLC accounts for 85 of lung cancer patients Adenocarcinoma and squamous cell carcinoma accounts for 40 and 25-30 of NSCLC patients respectively More than 75 of patients are diagnosed with stage III and IV lung cancer The age-standardized one-year overall survival rate of stage III and IV NSCLC are 35-46 and 159-156 respectively Therefore the management of locally advanced and metastatic lung cancer is important to improve the overall survival of NSCLC patients
The management of locally advanced and metastatic NSCLC is actionable driver mutation dependent Patients are recommended to have tissue biopsy to detect the actionable driver mutation Epidermal growth factor receptor EGFR mutation accounts for 554 of actionable driver mutation in Hong Kong Patients with EGFR mutation positive are recommended to receive EGFR tyrosine kinase inhibitor EGFR-TKI by the European Society of Medical Oncology and the National Comprehensive Cancer Network Anaplastic lymphoma kinase ALK is another common is actionable driver mutation with tyrosine kinase inhibitor TKI including crizotinib ceritinib alectinib brigatinib and lorlatinib
Paronychia is one of the common adverse events in patients who receive EGFR-TKIs and other TKI 176-57 of patients experienced paronychia in randomized controlled trials There were 06-11 of patients who experienced grade 3 paronychia according to the Common Terminology Criteria for Adverse Events version 50 CTCAEv50 in randomized controlled trials
Timolol and betaxolol are beta-blockers which are hypothesized to be effective in managing paronychia Beta-blockers were effective in hemangiomas and has been the first line treatment for severe infantile hemangiomas Previous case reports and case series suggested the potential use of topical beta-blocker However the evidence of topical beta-blocker treatment was limited by small sample size and low level of evidence Therefore this study aims to compare the safety and efficacy of topical timolol with routine clinical care with paronychia fingernails toenails or both as an adverse effect of EGFR-TKI and ALK-TKI
This study would assess the clinical efficacy of add-on topical timolol 05 eye drops to betamethasone valerate 01 for the treatment of EGFR-TKI and ALK-TKI induced paronychia Eligible patients who develop paronychia affecting fingernails toenails or both will be included in this study They will be randomized in 11 ratio using computer-generated randomization list to receive either combination of topical timolol 05 eye drops and betamethasone valerate 01 lotion application twice daily or betamethasone valerate 01 lotion application twice daily Patients in timolol combination treatment group will receive topical timolol 05 eye drops twice daily with occlusion ie covered with adhesive badge and betamethasone valerate 01 lotion twice daily with occlusion for 1 month Patients in routine arm would receive the management according to routine clinical practice including prescription of betamethasone valerate 01 lotion twice daily for 1 month with occlusion For patients who do not have paronychia completely resolved after 4 weeks the treatment assigned will be continued for another 4 to 8 weeks up to 12 weeks to see the effect
The management of locally advanced and metastatic NSCLC is actionable driver mutation dependent Patients are recommended to have tissue biopsy to detect the actionable driver mutation Epidermal growth factor receptor EGFR mutation accounts for 554 of actionable driver mutation in Hong Kong Patients with EGFR mutation positive are recommended to receive EGFR tyrosine kinase inhibitor EGFR-TKI by the European Society of Medical Oncology and the National Comprehensive Cancer Network Anaplastic lymphoma kinase ALK is another common is actionable driver mutation with tyrosine kinase inhibitor TKI including crizotinib ceritinib alectinib brigatinib and lorlatinib
Paronychia is one of the common adverse events in patients who receive EGFR-TKIs and other TKI 176-57 of patients experienced paronychia in randomized controlled trials There were 06-11 of patients who experienced grade 3 paronychia according to the Common Terminology Criteria for Adverse Events version 50 CTCAEv50 in randomized controlled trials
Timolol and betaxolol are beta-blockers which are hypothesized to be effective in managing paronychia Beta-blockers were effective in hemangiomas and has been the first line treatment for severe infantile hemangiomas Previous case reports and case series suggested the potential use of topical beta-blocker However the evidence of topical beta-blocker treatment was limited by small sample size and low level of evidence Therefore this study aims to compare the safety and efficacy of topical timolol with routine clinical care with paronychia fingernails toenails or both as an adverse effect of EGFR-TKI and ALK-TKI
This study would assess the clinical efficacy of add-on topical timolol 05 eye drops to betamethasone valerate 01 for the treatment of EGFR-TKI and ALK-TKI induced paronychia Eligible patients who develop paronychia affecting fingernails toenails or both will be included in this study They will be randomized in 11 ratio using computer-generated randomization list to receive either combination of topical timolol 05 eye drops and betamethasone valerate 01 lotion application twice daily or betamethasone valerate 01 lotion application twice daily Patients in timolol combination treatment group will receive topical timolol 05 eye drops twice daily with occlusion ie covered with adhesive badge and betamethasone valerate 01 lotion twice daily with occlusion for 1 month Patients in routine arm would receive the management according to routine clinical practice including prescription of betamethasone valerate 01 lotion twice daily for 1 month with occlusion For patients who do not have paronychia completely resolved after 4 weeks the treatment assigned will be continued for another 4 to 8 weeks up to 12 weeks to see the effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None