Chemotherapy-induced Peripheral Neuropathy Clinical Trial
Official title:
A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
NCT number | NCT04917796 |
Other study ID # | 20-426 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 21, 2021 |
Est. completion date | May 21, 2025 |
Electroacupuncture (referred to as EA) may be an effective treatment for Chemotherapy-Induced Peripheral Neuropathy/CIPN pain. 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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | May 21, 2025 |
Est. primary completion date | May 21, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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