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L'essai clinique NCT04917796 pour Neuropathie périphérique induite par la chimiothérapie, Douleur nerveuse, Neuropathie, Neuropathie douloureuse, Douleur, NPIC (Neuropathie périphérique induite par la chimiothérapie) est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT04917796 est un essai interventionnel pour Neuropathie périphérique induite par la chimiothérapie, Douleur nerveuse, Neuropathie, Neuropathie douloureuse, Douleur, NPIC (Neuropathie périphérique induite par la chimiothérapie). Son statut actuel est : en recrutement. L'étude a débuté le 21 mai 2021 et vise à recruter 250 participants. Dirigé par Dana-Farber Cancer Institute, l'essai devrait être terminé d'ici le 24 avril 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 16 avril 2025.
Résumé succinct
This study is a randomized controlled trial of electroacupuncture (referred to as EA) versus sham acupuncture (referred to as EA) as effective treatments for Chemotherapy-Induced Peripheral Neuropathy/CIPN pain in cancer survivors.
Description détaillée
During the study, patients will be randomized to one of the two possible acupuncture treatment groups and receive 10 treatments over the course of 8 weeks and then enter a follow-up period. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.
Titre officiel
A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
Conditions
Neuropathie périphérique induite par la chimiothérapieDouleur nerveuseNeuropathieNeuropathie douloureuseDouleurNPIC (Neuropathie périphérique induite par la chimiothérapie)Autres identifiants de l'essai
- 23-510
Numéro NCT
Date de début (réel)
2021-05-21
Dernière mise à jour publiée
2025-04-16
Date de fin (estimée)
2026-04-24
Inscription (estimée)
250
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Chemotherapy-induced Peripheral Neuropathy
CIPN
Electroacupuncture
Cancer survivor
Acupuncture
Memorial Sloan Kettering Cancer Center
Neuropathy
Dana-Farber Cancer Institute
Neuropathic Pain
Pain Management
CIPN
Electroacupuncture
Cancer survivor
Acupuncture
Memorial Sloan Kettering Cancer Center
Neuropathy
Dana-Farber Cancer Institute
Neuropathic Pain
Pain Management
Objectif principal
Soins de soutien
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalElectroacupuncture Arm The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms. | Électroacupuncture Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks). |
Comparateur placeboSham Acupuncture Arm The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms. | acupuncture placebo Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks). |
Critère principal d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Difference of pain severity from baseline to 4 weeks after baseline. | The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form (BPI-SF) | 4 weeks |
Difference of pain severity from baseline to 8 weeks after baseline. | The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form | 8 weeks |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- English-proficient men and women aged ≥18 years
- Free of oncologic disease by clinical examination and history
- Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment
- Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia73
- Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week
- On a stable regimen (no change in the past three months) if taking anti-neuropathy or other pain medications
- Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period
- Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
- Patients with a pacemaker or other electronically charged medical device
- Use of acupuncture for symptom management within the past 12 months
Dana-Farber Cancer InstituteCentre de cancérologie Memorial Sloan KetteringPartie responsable de l'essai
Ting Bao, MD, Investigateur principal, Principal Investigator, Dana-Farber Cancer Institute
Contact central de l'essai
Contact: Ting Bao, MD, 857-215-2844, [email protected]
Contact: Natalie Viyaran, 617-582-8629, [email protected]
6 Centres de l'essai dans 1 pays
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Ting Bao, MD, Contact, 857-215-2844, [email protected]
Ting Bao, MD, Investigateur principal
En recrutement
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge, New Jersey, 07920, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
En recrutement
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, 07748, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
En recrutement
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
En recrutement
New York
Memorial Sloan - Kettering Cancer Center, New York, New York, 10021, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
En recrutement
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, 11553, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
En recrutement