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El ensayo clínico NCT04917796 para Neuropatía periférica inducida por quimioterapia, Dolor nervioso, Neuropatía, Neuropatía dolorosa, Dolor, Neuropatía periférica inducida por quimioterapia (CIPN) está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT04917796 es un ensayo intervencionista para Neuropatía periférica inducida por quimioterapia, Dolor nervioso, Neuropatía, Neuropatía dolorosa, Dolor, Neuropatía periférica inducida por quimioterapia (CIPN). Su estado actual es: reclutando. El ensayo se inició el 21 de mayo de 2021, con el objetivo de reclutar a 250 participantes. Dirigido por Dana-Farber Cancer Institute, se espera que finalice el 24 de abril de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 16 de abril de 2025.
Resumen
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.
Descripción detallada
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.
Título oficial
A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
Condiciones médicas
Neuropatía periférica inducida por quimioterapiaDolor nerviosoNeuropatíaNeuropatía dolorosaDolorNeuropatía periférica inducida por quimioterapia (CIPN)Otros ID del ensayo
- 23-510
Número del NCT
Inicio del ensayo (real)
2021-05-21
Última actualización
2025-04-16
Fecha de finalización (estimada)
2026-04-24
Inscripción (prevista)
250
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
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
Objetivo principal
Cuidados de apoyo
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalElectroacupuncture 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. | Electroacupuntura 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). |
Comparador 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. | acupuntura simulada 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). |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- 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 InstituteCentro Nacional del Cáncer, JapónParte responsable del ensayo
Ting Bao, MD, Investigador principal, Principal Investigator, Dana-Farber Cancer Institute
Contactos centrales del ensayo
Contacto: Ting Bao, MD, 857-215-2844, [email protected]
Contacto: Natalie Viyaran, 617-582-8629, [email protected]
6 Sitios del ensayo en 1 países
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Ting Bao, MD, Contacto, 857-215-2844, [email protected]
Ting Bao, MD, Investigador principal
Reclutando
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge, New Jersey, 07920, United States
Jun Mao, MD, MSCE, Contacto, 646-888-0863
Reclutando
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, 07748, United States
Jun Mao, MD, MSCE, Contacto, 646-888-0863
Reclutando
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
Jun Mao, MD, MSCE, Contacto, 646-888-0863
Reclutando
New York
Memorial Sloan - Kettering Cancer Center, New York, New York, 10021, United States
Jun Mao, MD, MSCE, Contacto, 646-888-0863
Reclutando
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, 11553, United States
Jun Mao, MD, MSCE, Contacto, 646-888-0863
Reclutando