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Capsaicin Patch vs Duloxetine in Chemotherapy-induced Peripheral Neuropathy
NCT05840562Phase 3
Key facts
- Status
- Recruiting
- Start
- Oct 2023
- Primary completion
- Mar 2028
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- capsaicin
- Conditions
- chemotherapy-induced peripheral neuropathy (CIPN)
01
Overview
Phase 3, randomised, open-label trial of capsaicin in chemotherapy-induced peripheral neuropathy (CIPN) (2 arms), sponsored by Institut Cancérologique de l'Ouest. Primary endpoint: Improvement in painful CIPN at 5 weeks. Started Oct 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Experimental Arm
Capsaicin 179 mg patch applied to painful extremities for 30-60 minutes.
Control Arm
Duloxetine 30 mg orally for 1 week followed by 60 mg per day.
03
Who it enrols
Adult patients with painful chemotherapy-induced peripheral neuropathy (CIPN) persisting at least 1 month after taxane and/or platinum salt chemotherapy, with a pain score >= 4/10, excluding those with pre-existing neuropathy of other etiologies, uncontrolled hypertension, or recent cardiovascular events.
04
Endpoints
Primary
Improvement in painful CIPN
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