Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Nerve Pain, Neuropathy, Neuropathy, Painful, Pain
Conditions
Keywords
Chemotherapy-induced Peripheral Neuropathy, CIPN, Electroacupuncture, Cancer survivor, Acupuncture, Memorial Sloan Kettering Cancer Center, Neuropathy, Dana-Farber Cancer Institute, Neuropathic Pain, Pain Management
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 (CIPN) pain in cancer survivors.
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.
Interventions
OTHERElectroacupuncture
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).
OTHERSham Acupuncture
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).
Sponsors
Dana-Farber Cancer Institute
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Randomization will occur before the baseline assessments are administered. Each site will randomize its own patients through RedCap. Once the patient is randomized, the site acupuncture team will be notified via RedCap alert in order to provide the appropriate treatment. Patients and non-acupuncturist members of the study team will be blinded to which acupuncture group the patient was assigned. The acupuncturists and one clinical research coordinator will be the only ones unblinded. The clinical research coordinator will be unblinded in order to assist acupuncturists to confirm randomization. This clinical research coordinator will not be the primary research coordinator in the study and will not have direct contact with the patient. The rest of the study coinvestigators and staff will remain blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of pain severity from baseline to 4 weeks after baseline. | 4 weeks | 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) |
| Difference of pain severity from baseline to 8 weeks after baseline. | 8 weeks | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWeidong Lu, PhD, MPH
Dana-Farber Cancer Institute
Outcome results
None listed