Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN) Using a Point-Of-Nerve Conduction Device (NeuroMetrix) and the Rydel-Seiffer Tuning Fork
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Accessing Level of Peripheral Neuropathy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
- •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.
结局指标
主要结局
Accessing Level of Peripheral Neuropathy
时间窗: Baseline to 30 days after 3 week treatment sessions
Participants with chemotherapy-induced peripheral neuropathy (CIPN) will have their level of periphal neuropathy assessed with the Rydel-Seiffer Tuning Fork while using a point-of-care conduction device (NeuroMetrix). The level of periphal neuropathy will be measured by vibration detection using a Rydel-Seiffer graduated tuning fork placed on the dorsum of the right great toe between the nail and the distal interphalangeal joint. The two arms of the 128 Hz tuning fork are fitted with calibrated weights at the ends, and as the amplitude decreases, the intersection of the triangles moves upward on the weight. This test will be performed three times and a mean of the scores calculated. Vibration sensation is lost sooner in CIPN, which means that lower scores are associated with increased CIPN.
次要结局
- Quality of life Improvement measured with FACT/GOG-NTX Questionnaire(Baseline to 30 days after 3 week treatment sessions)
- Quality of life Improvement measured the Neuropathic pain scale (NPS)(Baseline to 30 days after 3 week treatment sessions)