Chemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%.

NCT07602387 | Recruiting

• 2 other identifiers: 2023-012023-A00325-40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patients With Taxane-induced Chronic Neuropathic Pain

Keywords

chronic neuropathic pain; taxanes; moderate to severe pain; skin biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (1)

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

  From enrollment to the end of treatment at 12 months.

Study Arms (2)

capsaicin 8%

ACTIVE COMPARATOR

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).

Drug: Capsaicin 8% Patch

other treatments

ACTIVE COMPARATOR

Other treatments for neuropathic pain include antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation according to the 2020 French recommendations.

Drug: antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation

Interventions

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

capsaicin 8%

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.

other treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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
• Uncontrolled chronic pathology such as morbid obesity, sleep apnea, uncontrolled hypertension, etc.
• Psychosis, previous suicide attempt, or major depressive episode at the time of assessment
• Drug or psychoactive substance abuse
• Cognitive or psychological disorders incompatible with compliance with and/or understanding of the protocol
• Patients participating in another biomedical research protocol
• Contraindications to confocal corneal microscopy, including the wearing of long-term contact lenses or ocular procedures (eye surgery, laser for myopia, dry eye).
• Pregnant or breastfeeding women
• Persons under legal protection

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead
• Institut Curie: collaborator
• Grünenthal GmbH: collaborator

Study Sites (1)

Inserm U987

Boulogne-Billancourt, HAUTS DE SEINE, 92100, France

RECRUITING

MeSH Terms

Interventions

Capsaicin; Transdermal Patch; Antidepressive Agents; Antidepressive Agents, Tricyclic

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Didier BOUHASSIRA, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Central Study Contacts

Didier BOUHASSIRA, MD, PhD

CONTACT

0033149094556; didier.bouhassira@inserm.fr

Marie PECHARD, MD

CONTACT

0033147111515; marie.pechard@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: May 22, 2026
• Study Start: March 12, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2025-09

Locations

FR (1)