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De klinische studie NCT04917796 voor Door chemotherapie geïnduceerde perifere neuropathie, Zenuwpijn, Neuropathie, Pijnlijke neuropathie, Pijn, CIPN - door chemotherapie geïnduceerde perifere neuropathie is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
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De klinische studie NCT04917796 is een interventioneel studie bij Door chemotherapie geïnduceerde perifere neuropathie, Zenuwpijn, Neuropathie, Pijnlijke neuropathie, Pijn, CIPN - door chemotherapie geïnduceerde perifere neuropathie met de status recruterend. Het doel is om 250 deelnemers te includeren vanaf 21 mei 2021. De studie wordt geleid door Dana-Farber Cancer Institute en de voltooiing is gepland op 24 april 2026. Laatste update op ClinicalTrials.gov: 16 april 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.
Officiële titel
A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
Aandoeningen
Door chemotherapie geïnduceerde perifere neuropathieZenuwpijnNeuropathiePijnlijke neuropathiePijnCIPN - door chemotherapie geïnduceerde perifere neuropathieAndere studie-ID's
- 23-510
NCT-ID
Startdatum (Werkelijk)
2021-05-21
Laatste update geplaatst
2025-04-16
Verwachte einddatum
2026-04-24
Inschrijving (Geschat)
250
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
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
Primaire doel
Ondersteunende zorg
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelElectroacupuncture 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. | Electroacupunctuur 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). |
Placebo-comparatorSham 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. | Nepacupunctuur 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). |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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 InstituteMemorial Sloan Kettering KankercentrumVerantwoordelijke instantie
Ting Bao, MD, Hoofdonderzoeker, Principal Investigator, Dana-Farber Cancer Institute
Centraal Contactpersoon
Contact: Ting Bao, MD, 857-215-2844, [email protected]
Contact: Natalie Viyaran, 617-582-8629, [email protected]
6 Studielocaties in 1 landen
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Ting Bao, MD, Contact, 857-215-2844, [email protected]
Ting Bao, MD, Hoofdonderzoeker
Recruterend
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
Recruterend
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, 07748, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
Recruterend
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
Recruterend
New York
Memorial Sloan - Kettering Cancer Center, New York, New York, 10021, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
Recruterend
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, 11553, United States
Jun Mao, MD, MSCE, Contact, 646-888-0863
Recruterend