Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN) (NCT04092764) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN)
United States23 participantsStarted 2020-01-23
Plain-language summary
The purpose of the study is to determine the validity of a point-of-care nerve conduction device (NeuroMetrix) and Rydel-Seiffer tuning fork in assessing the level of peripheral neuropathy in patients with chemotherapy-induced peripheral neuropathy (CIPN). Chemotherapy-induced peripheral neuropathy (CIPN) is a common, persistent toxicity among patients who receive chemotherapy. It is characterized by a variety of sensory and motor symptoms such as numbness, tingling, reduced sense of touch, reduced proprioception (awareness of your limb and body position in space), pain, weakness, balance disturbances, and deficits in motor skills.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have undergone chemotherapy with taxane and/or platinum agent
* Presence of numbness, paresthesias, loss of deep tendon reflexes, or other symptoms in the lower extremities those were absent prior to treatment with neurotoxic chemotherapy.
* Three or more months status post platinum containing chemotherapy completion
* Grade ≥1 Level of CIPN that is determined by the NCI Common Toxicity Criteria for Adverse Events.
Exclusion Criteria:
* Peripheral neuropathy from causes other than chemotherapy, such as documented
* a. Nerve compression (carpal tunnel syndrome, sciatica, etc)
* b. Previously known leptomeningeal carcinomatosis
* c. Evidence of disease in the brain or spine by prior imaging
* Comorbidities with documented pre-existing neuropathy prior to the chemotherapy such as
* a. Diabetes (HbA1c 6.5% or greater)
* b. HIV
* c. Multiple myeloma
* d. Alcoholism
* Pain medication dosing, including opioids, anti-convulsants, and anti- depressantshas been increased due to worsening symptoms less than in the two weeks prior to study registration
* Current use of acupuncture (manual or electro acupuncture)
* Pregnancy
* Cardiac issues (AHA class 3 or greater)
* Pacemaker or an imbedded neural stimulator
* Full therapeutic anticoagulation or a INR \> 1.4
* Currently undergoing chemotherapy with a platinum agent or have received a platinum chemotherapy agent in the past 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accessing Level of Peripheral Neuropathy
Timeframe: Baseline to 30 days after 3 week treatment sessions
Trial details
NCT IDNCT04092764
SponsorH. Lee Moffitt Cancer Center and Research Institute