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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
France
Inserm U987
RECRUITING
Boulogne-billancourt
Contact Information
Primary
Didier BOUHASSIRA, MD, PhD
didier.bouhassira@inserm.fr
0033149094556
Backup
Marie PECHARD, MD
marie.pechard@curie.fr
0033147111515
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2028-03
Participants
Target number of participants: 50
Treatments
Active_comparator: capsaicin 8%
The minimum time between 2 applications of capsaicin is 60 days, but this could be adapted to the patients' response and therefore could be longer (up to 3 months). Thus, skin biopsies will be performed before the first capsaicin application and before the third application, that is to say 4 to 6 months after the first application. Patients will continue then to be followed for up to one year and another skin punch biopsy will be performed after the fifth 8% capsaicin application (i.e. 8 to 12 months after the first application).
Active_comparator: other treatments
Other treatments for neuropathic pain include antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation according to the 2020 French recommendations.
Related Therapeutic Areas
Sponsors
Collaborators: Institut Curie, Grünenthal GmbH
Leads: Hospital Ambroise Paré Paris

This content was sourced from clinicaltrials.gov