Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840562
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-04-21
Brief Title:
Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy
Sponsor:
Institut Cancerologie de lOuest
Organization:
Institut Cancerologie de lOuest
Study Overview
Official Title:
Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy a Phase 3 Randomized Multicentric Open-label Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPNEUCHIM
Brief Summary:
Chemotherapy induced peripheral neuropathy CIPN is a frequent and disabling complication of systemic chemotherapy particularly with oxaliplatin or taxanes The incidence of CIPN is variable but approximately 30-40 of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes or oxaliplatin
This CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness tingling and less frequently shootingburning pain These symptoms spread proximally to affect both lower and upper extremities in a characteristic stocking and glove distribution
Many symptoms of CIPN may resolve completely for some patients However CIPN is only partly reversible for most In the worst instances it does not appear to be reversible at all and can even increase over time
CIPN is difficult to manage Only duloxetine is recommended based on the positive result of a randomized phase III double-blind placebo-controlled crossover trial The use of duloxetine resulted in a greater reduction in pain and was effective in decreasing numbness and tingling in the feet But systemic antidepressants are often associated with toxicities and patients often refuse or abandon the treatment
Capsaicin inhibits neural transmission in sensory axons and has been proven as effective on the intensity of pain for post-herpetic neuralgia and human immunodeficiency virus-associated neuropathy Efficacy appears at one month and persists for at least 2 months
Only a few studies focused on the efficacy of capsaicin 179 mg patch on the intensity of CIPN-induced pain These non-randomized studies show that more than 50 of patients have a reduction in pain intensity of more than 30
Until now no clinical trial has compared the efficacy of the capsaicin 179 mg patch with duloxetine
Accordingly this open-label phase 3 randomized multicenter trial will compare efficacy and safety of capsaicin patch with oral duloxetine on painful CIPN persisting more than 3 months after the end of the responsible chemotherapy
This CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness tingling and less frequently shootingburning pain These symptoms spread proximally to affect both lower and upper extremities in a characteristic stocking and glove distribution
Many symptoms of CIPN may resolve completely for some patients However CIPN is only partly reversible for most In the worst instances it does not appear to be reversible at all and can even increase over time
CIPN is difficult to manage Only duloxetine is recommended based on the positive result of a randomized phase III double-blind placebo-controlled crossover trial The use of duloxetine resulted in a greater reduction in pain and was effective in decreasing numbness and tingling in the feet But systemic antidepressants are often associated with toxicities and patients often refuse or abandon the treatment
Capsaicin inhibits neural transmission in sensory axons and has been proven as effective on the intensity of pain for post-herpetic neuralgia and human immunodeficiency virus-associated neuropathy Efficacy appears at one month and persists for at least 2 months
Only a few studies focused on the efficacy of capsaicin 179 mg patch on the intensity of CIPN-induced pain These non-randomized studies show that more than 50 of patients have a reduction in pain intensity of more than 30
Until now no clinical trial has compared the efficacy of the capsaicin 179 mg patch with duloxetine
Accordingly this open-label phase 3 randomized multicenter trial will compare efficacy and safety of capsaicin patch with oral duloxetine on painful CIPN persisting more than 3 months after the end of the responsible chemotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None