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O estudo clínico NCT04917796 para Neuropatia periférica induzida por quimioterapia, Dor nervosa, Neuropatia, Neuropatia Dolorosa, Dor, NIPQ - neuropatia periférica induzida por quimioterapia está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT04917796 é um ensaio intervencionista para Neuropatia periférica induzida por quimioterapia, Dor nervosa, Neuropatia, Neuropatia Dolorosa, Dor, NIPQ - neuropatia periférica induzida por quimioterapia. Seu status atual é: recrutando. O estudo começou em 21 de maio de 2021 e pretende incluir 250 participantes. Coordenado por Dana-Farber Cancer Institute e deve ser concluído em 24 de abril de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 16 de abril de 2025.
Resumo
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.
Descrição detalhada
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)
Condições
Neuropatia periférica induzida por quimioterapiaDor nervosaNeuropatiaNeuropatia DolorosaDorNIPQ - neuropatia periférica induzida por quimioterapiaOutros IDs do estudo
- 23-510
Número NCT
Data de início (real)
2021-05-21
Última atualização postada
2025-04-16
Data de conclusão (estimada)
2026-04-24
Inscrição (estimada)
250
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Palavras-chave
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
Propósito principal
Cuidados de suporte
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Simples-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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. | Eletroacupuntura 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). |
Desfecho primário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
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 de Câncer Memorial Sloan KetteringResponsável pelo estudo
Ting Bao, MD, Investigador principal, Principal Investigator, Dana-Farber Cancer Institute
Contato central do estudo
Contato: Ting Bao, MD, 857-215-2844, [email protected]
Contato: Natalie Viyaran, 617-582-8629, [email protected]
6 Locais do estudo em 1 países
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Ting Bao, MD, Contato, 857-215-2844, [email protected]
Ting Bao, MD, Investigador principal
Recrutando
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge, New Jersey, 07920, United States
Jun Mao, MD, MSCE, Contato, 646-888-0863
Recrutando
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, 07748, United States
Jun Mao, MD, MSCE, Contato, 646-888-0863
Recrutando
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
Jun Mao, MD, MSCE, Contato, 646-888-0863
Recrutando
New York
Memorial Sloan - Kettering Cancer Center, New York, New York, 10021, United States
Jun Mao, MD, MSCE, Contato, 646-888-0863
Recrutando
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, 11553, United States
Jun Mao, MD, MSCE, Contato, 646-888-0863
Recrutando