Status:
RECRUITING
The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Nerve Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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. Acupunctur...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with a pacemaker or other electronically charged medical device
- Use of acupuncture for symptom management within the past 12 months
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 24 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04917796
Start Date
May 21 2021
End Date
April 24 2026
Last Update
April 16 2025
Active Locations (6)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645