Electroacupuncture for nerve pain from chemotherapy
A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
This study is testing if electroacupuncture can help cancer survivors with nerve pain caused by chemotherapy feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Trial ID | NCT04917796 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of electroacupuncture compared to sham acupuncture in treating chemotherapy-induced peripheral neuropathy (CIPN) pain in cancer survivors. Participants will be randomly assigned to receive either electroacupuncture or sham treatment over 10 sessions within an 8-week period, followed by a follow-up phase. Electroacupuncture involves the application of a small electrical current through acupuncture needles, which may enhance pain relief. The goal is to determine if this method can alleviate CIPN symptoms and improve overall quality of life for patients.
Who should consider this trial
Good fit: Ideal candidates are English-proficient adults aged 18 and older who have completed neurotoxic chemotherapy and experience moderate to severe CIPN pain.
Not a fit: Patients currently undergoing chemotherapy or those with ongoing oncologic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce nerve pain and improve the quality of life for cancer survivors suffering from CIPN.
How similar studies have performed: Previous studies have shown promising results for acupuncture in managing pain, suggesting that this approach may be effective for CIPN, although the specific use of electroacupuncture in this context is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patients with a pacemaker or other electronically charged medical device * Use of acupuncture for symptom management within the past 12 months
Where this trial is running
Boston, Massachusetts and 5 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Memorial Sloan Kettering Basking Ridge (Limited protocol activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan - Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ting Bao, MD — Dana-Farber Cancer Institute
- Study coordinator: Ting Bao, MD
- Email: ting_bao@dfci.harvard.edu
- Phone: 857-215-2844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.