The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
NCT ID: NCT04917796
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2021-05-21
2026-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Electroacupuncture 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.
Electroacupuncture
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).
Sham 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.
Sham Acupuncture
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).
Interventions
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Electroacupuncture
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).
Sham Acupuncture
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Use of acupuncture for symptom management within the past 12 months
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Ting Bao, MD
Principal Investigator
Principal Investigators
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Ting Bao, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Related Links
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Dana-Farber Cancer Institute
Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-510
Identifier Type: -
Identifier Source: org_study_id
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