Status:
COMPLETED
Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN)
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04092764
Start Date
January 23 2020
End Date
November 11 2021
Last Update
November 7 2022
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612