Inserm U987
Boulogne-Billancourt, HAUTS DE SEINE, 92100, France
Location status: Recruiting
Location contact
Didier BOUHASSIRA, MD PHD
CONTACT
MARIE PECHARD, MD
CONTACT
NCT Number: NCT07602387
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boulogne-Billancourt, HAUTS DE SEINE, 92100, France
Location status: Recruiting
Didier BOUHASSIRA, MD PHD
CONTACT
MARIE PECHARD, MD
CONTACT
The 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).
To analyze the relationships between the structural (i.e. fiber density) and functional (i.e. laser evoked potentials (PEL), QST and Sudoscan) changes in small fibers and the clinical effects of the treatment on pain intensity in the 2 groups.
To verify whether the measurement of small corneal fiber density before treatment by the non-invasive technique of corneal confocal microscopy (CCM) (which is known to be correlated with lower limb small fiber density), could be predictive of the response to capsaicin 8%.
An interim analysis will be requested from the ethics committee in France to analyze the data of the first 30 patients
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
These treatments are administered to patients according to the French recommendations on the management of neuropathic pain from 2020.
Time frame: From enrollment to the end of treatment at 12 months
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.
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.
Contact information is provided by the study sponsor or research team.
Hospital Ambroise Paré Paris
Other
Chemotherapy Induced Peripheral Neuropathy by Taxanes: Pathophysiological Evolution and Somatosensory Response Profile to Capsaicin 8%.
Acronym: capsaNeP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.