Chemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%. (capsaNeP)
Chemotherapy Induced Peripheral Neuropathy by Taxanes: Pathophysiological Evolution and Somatosensory Response Profile to Capsaicin 8%.
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Didier BOUHASSIRA, MD, PhD
- 전화번호: 0033149094556
- 이메일: didier.bouhassira@inserm.fr
연구 연락처 백업
- 이름: Marie PECHARD, MD
- 전화번호: 3683 0033147111515
- 이메일: marie.pechard@curie.fr
연구 장소
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HAUTS DE SEINE
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Boulogne-Billancourt, HAUTS DE SEINE, 프랑스, 92100
- 모병
- Inserm U987
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연락하다:
- Didier BOUHASSIRA, MD PHD
- 전화번호: 0033149094556
- 이메일: didier.bouhassira@inserm.fr
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연락하다:
- MARIE PECHARD, MD
- 전화번호: 0033149095946
- 이메일: marie.pechard@curie.fr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion 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 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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).
|
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
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활성 비교기: 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.
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These treatments are administered to patients according to the French recommendations on the management of neuropathic pain from 2020.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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density of small nerve fibers
기간: From enrollment to the end of treatment at 12 months
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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patient reported outcomes and skin biopsy; CCM and skin biopsy; PEL and skin biopsy
기간: From enrollment to the end of treatment at 12 months.
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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. |
From enrollment to the end of treatment at 12 months.
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 책임자: Didier BOUHASSIRA, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2023-01
- 2023-A00325-40 (기타 식별자: 2023-A00325-40)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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