Chemotherapy-induced Peripheral NeuropathyACTNCT04917796
The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
A study testing Electroacupuncture in people with Chemotherapy-induced Peripheral Neuropathy and Nerve Pain, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial 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 (CIPN) pain in cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Nerve Pain, Neuropathy
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 May 2021to 24 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 paresthesia
- 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
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- 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
Who cannot join
- Patients with a pacemaker or other electronically charged medical device
- Use of acupuncture for symptom management within the past 12 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, 07920
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553
About this study
Official title: A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
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.
Read the 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. 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.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Nerve Pain, Neuropathy, Neuropathy, Painful, Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Being tested
- Electroacupuncture, Sham Acupuncture
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, CIPN, Electroacupuncture, Cancer survivor, Acupuncture, Memorial Sloan Kettering Cancer Center, Neuropathy, Dana-Farber Cancer Institute, Neuropathic Pain, Pain Management
- Medical subject headings
- Neuralgia, Neuropathy, Painful, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
Also called EA
Real and sham acupuncture will be delivered by experienced licensed acupuncturists. 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 AcupunctureOther
Real and sham acupuncture will be delivered by experienced licensed acupuncturists. 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).
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture Arm | Experimental | 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. Receives: Other: Electroacupuncture |
| Sham Acupuncture Arm | Placebo comparator | 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. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start21 May 2021
- Primary completion24 Sep 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Principal investigator, Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute
- Investigators
- Weidong Lu, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917796
- Sponsor's protocol ID
- 23-510
- Acronym
- ACT
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Ting Bao, MD at ting\_bao@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.