Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy - Trial NCT05840562

Timeline & Enrollment

Primary Outcome

The primary objective is to demonstrate that capsaicin 179 mg patch once compared to duloxetine daily, improves painful CIPN after a 5-week treatment period.

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 shooting/burning 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.

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