RecruitingNot ApplicableNCT07602387

Chemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%.

Chemotherapy Induced Peripheral Neuropathy by Taxanes: Pathophysiological Evolution and Somatosensory Response Profile to Capsaicin 8%.


Sponsor

Hospital Ambroise Paré Paris

Enrollment

50 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Capsaicin 8% Patch and a drug called antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation for people with patients with taxane-induced chronic neuropathic pain. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCapsaicin 8% Patch

The hypothesis 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 (in particular the changes in the membrane excitability responsible for pain). Thus, capsaicin could, in this specific clinical context, have a "curative" effect on neuropathic pain. However, since the action of capsaicin only concerns small fibers, one cannot expect a global improvement of the neuropathy, which affects all the fibers

DRUGantidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation

These treatments are administered to patients according to the French recommendations on the management of neuropathic pain from 2020.


Locations(1)

Inserm U987

Boulogne-Billancourt, HAUTS DE SEINE, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07602387