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New treatment option for Patients With Taxane-induced Chronic Neuropathic Pain
Official title Chemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%.
ClinicalTrials.gov ID: NCT07602387
What this study is testing
What is Capsaicin 8% Patch?
Capsaicin 8% Patch is an investigational medicine, being studied as a potential treatment for patients with taxane-induced chronic neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boulogne-Billancourt, HAUTS DE SEINE, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulogne-Billancourt, HAUTS DE SEINE, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.