Chemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Ambroise Paré Paris

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

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital Ambroise Paré Paris

Lead sponsor

Institut Curie

Sponsor institution

Institut Curie

Collaborator

Grünenthal GmbH

Collaborator