About this trial
The goal of this study is to compare the evolution of the density of small nerve fibers assessed with skin biopsies at the foot between two groups of patients with taxane-induced chronic neuropathic pain matched for sex and age: one group treated with applications of capsaicin 8% and a control group who received a systemic treatment. The hypothesis for the capsaicin 8% arm is that in the chronic phase, in the absence in the nervous environment of the toxic agent (in this case taxanes) causing the neuropathy and the functional modifications at the origin of pain, the new small fibers could regenerate without these pathological alterations.
Our analysis will be based on the demonstration of structural abnormalities of small nerve fibers by means of skin biopsy, but also of functional abnormalities using four validated tests commonly used in this field: quantitative sensory testing (QST), laser evoked potential recordings, Sudoscan and confocal corneal microscopy.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Capsaicin 8% Patch
- antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation
Treatment groups
Sponsors and collaborators
Hospital Ambroise Paré Paris
Lead sponsor
Institut Curie
Sponsor institution
Institut Curie
Collaborator
Grünenthal GmbH
Collaborator