Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy: a Phase 3 Randomized Multicenter Open-label Study

What this Trial Is About

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often disabling side effect of chemotherapy drugs like oxaliplatin and taxanes. It mainly causes sensory nerve problems such as numbness, tingling, and sometimes burning pain, typically affecting the hands and feet in a "glove and stocking" pattern. While some patients experience symptom improvement over time, many have lasting or worsening symptoms. The trial aims to compare two treatments for painful CIPN that lasts more than three months after chemotherapy ends. This phase 3, open-label, randomized study compares the effectiveness and safety of a capsaicin 179 mg patch versus oral duloxetine. The capsaicin patch is applied to the most painful areas on the hands or feet, remaining for 30 minutes to an hour depending on the location and tolerance. Treatment may involve up to four sessions in one application, with repeat applications every two months if pain persists. Duloxetine is given orally, starting at 30 mg daily for one week, then increasing to 60 mg daily, with a possible increase to 120 mg if needed after six weeks. Participants will be monitored over a five-week treatment period to see which treatment better reduces pain from CIPN. Assessments include pain scores using the Brief Pain Inventory-Short Form (BPI-SF). Researchers will also evaluate safety and tolerability during the study. The trial involves regular medical follow-up and adherence to treatment schedules, with participation lasting at least five weeks and potential longer-term monitoring depending on treatment response.

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