Clinical trial NCT04092764: Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN)
Official title: Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN) Using a Point-Of-Nerve Conduction Device (NeuroMetrix) and the Rydel-Seiffer Tuning Fork
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Numbness
Pain
Tingling
Reduced sense of touch
Reduced proprioception
Sensory Neuropathy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with Sensory Neuropathy
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accessing Level of Peripheral Neuropathy
timeFrame: Baseline to 30 days after 3 week treatment sessions
Secondary outcomes:
measure: Quality of life Improvement measured with FACT/GOG-NTX Questionnaire
timeFrame: Baseline to 30 days after 3 week treatment sessions
measure: Quality of life Improvement measured the Neuropathic pain scale (NPS)
timeFrame: Baseline to 30 days after 3 week treatment sessions
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Hye Sook Chon, MD
role: PRINCIPAL_INVESTIGATOR
References: