Capsaicin 8% Patch for Taxane-Induced Neuropathic Pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with taxane-induced neuropathic pain are assigned to receive capsaicin 8% patches versus a comparator treatment. The study tracks structural changes in small nerve fibers via skin biopsies and evaluates functional changes with tests such as quantitative sensory testing, laser-evoked potentials, Sudoscan, and corneal confocal microscopy. Skin biopsies occur before the first patch and again after several patch applications, with follow-up up to a year. An interim ethics review will assess data from the first 30 patients. The goal is to link structural and functional nerve changes with pain outcomes and to explore whether corneal nerve density can predict response to capsaicin.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients over 18 years of age with no age limit
* having given their signed consent for participation in the study
* affiliated with the social security system
* able to be followed for the entire duration of the study
* reading and understanding French
* accepting the principle of the study and able to respect its conditions
* presenting sensorimotor or sensory neuropathy induced by taxanes (paclitaxel or docetaxel) of the lower limbs for at least 3 months based on a complete clinical examination, the severity of which will be assessed by the NCI-CTCAE version 5 criteria (grade 2 to 4). An electromyogram (EMG) will be performed in the absence of a recent electromyogram (less than one year) to assess the function of large fibers, but its normality will not constitute an exclusion criterion (due to the possibility of chemotherapy-induced small fiber neuropathies).
* presenting chronic neuropathic pain in the lower limbs for at least 3 months, with a DN4 questionnaire score ≥ 4/10 and of at least moderate intensity on an 11-point numerical scale (≥ 4/10)
* whose pain is located in the lower limbs allowing the application of 8% capsaicin
* without treatment or having stable analgesic treatment for at least 2 weeks before inclusion

Exclusion Criteria:

* litigation or compensation-seeking
* metastatic cancer
* Known cause of sensory neuropathy such as diabetes, systemic disease, hypothyroidism, alcohol, kidney failure, or genetic disease
* Peripheral or central nervous system pathology with or without associated neuropathic pain
* Uncontrolled chronic pathology such as morbid obesity, sleep apnea, uncontrolled hypertension, etc.
* Psychosis, previous suicide attempt, or major depressive episode at the time of assessment
* Drug or psychoactive substance abuse
* Cognitive or psychological disorders incompatible with compliance with and/or understanding of the protocol
* Patients participating in another biomedical research protocol
* Contraindications to confocal corneal microscopy, including the wearing of long-term contact lenses or ocular procedures (eye surgery, laser for myopia, dry eye).
* Pregnant or breastfeeding women
* Persons under legal protection

Where it's running

• Inserm U987
  Boulogne-Billancourt, Hauts de Seine, France Recruiting

Study contacts

• Study coordinator: Didier BOUHASSIRA, MD, PhD
• Email: didier.bouhassira@inserm.fr
• Phone: 0033149094556

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.