Chemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%.

ConditionPatients With Taxane-induced Chronic Neuropathic Pain

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Capsaicin 8% Patch
Drug
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
antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation
Drug
These treatments are administered to patients according to the French recommendations on the management of neuropathic pain from 2020.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: capsaicin 8%Active comparator 1 intervention

Group B: other treatmentsActive comparator 1 intervention

Trial outcomes

Primary outcomes

density of small nerve fibers

This clinical trial is a pathophysiology protocol. The primary objective of this study is to compare baseline at 3 and 12 months the density of small nerve fibers in the feet using a skin biopsy between two groups of patients with taxane-induced chronic neuropathic pain matched for sex and age. One group treated with two applications of capsaicin 8% and a control group who received a systemic treatment. All treatments used in the clinical trial are recommended by international experts for treating neurpathic pain and are approved by the French Medicines Agency.

Time frame

From enrollment to the end of treatment at 12 months

Secondary outcomes

patient reported outcomes and skin biopsy; CCM and skin biopsy; PEL and skin biopsy

Correlation between intraepidermal nerve fiber density (skin biopsy) and pain (11-point numerical rating scale, Brief Pain Inventory, Neuropathic Pain Symptom Inventory, EORTC CIPN20, catastrophizing) and other domains to be studied in clinical trials on chronic pain (EQ5D quality of life, PROMIS sleep, IPAQ physical activity, Beck Depression Inventory anxiety). Correlation between intraepidermal nerve fiber density (skin biopsy) and small nerve fiber functionality (Sudoscan, laser evoked potentials). Correlation between baseline nerve fiber density assessed by confocal corneal microscopy and the efficacy of 8% capsaicin.

Time frame

From enrollment to the end of treatment at 12 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Ambroise Paré Paris

Lead sponsor

Institut Curie

Sponsor institution

Institut Curie

Collaborator

Grünenthal GmbH