Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 30
- 主要终点
- Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
研究概览
简要总结
This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy refers to the conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased. The TENS device emits high frequency electrical stimulation through the skin and may provide relief from chronic pain.
详细描述
PRIMARY OBJECTIVE:
I. Obtain efficacy estimates of daily TENS on CIPN (European Organization for Research and Treatment of Cancer-CIPN20 [EORTC-CIPN20]) to inform the design of a phase III confirmatory trial.
SECONDARY OBJECTIVES:
I. Obtain efficacy estimates of TENS on individual CIPN symptoms (i.e., hot/burning pain, sharp/shooting pain, tingling, numbness, cramping (measured daily via 0 - 10 numeric rating scale [NRS]).
II. Evaluate the feasibility of conducting, within the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) network, a multisite, modified double-blind randomized control trial (RCT) of TENS for CIPN with physiologic assessments of descending inhibition (i.e., conditioned pain modulation [CPM] test) by assessing the proportions of (a) screened patients who enroll, (b) randomized participants who adhere to the treatment and complete the primary assessment, and (c) randomized participants who complete the CPM test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Have completed treatment with a platinum agent, taxane, vinca alkaloid, or bortezomib at least 3 months prior to registration
- •Have a clinical diagnosis of CIPN from their physician or physician designee based on the following criteria: bilateral (i.e., present on both sides of the body), abnormal sensory symptoms in their feet or legs (e.g., hot/burning pain, sharp/shooting pain, numbness, tingling, cramping)
- •Report at least 1 non-painful symptom associated with CIPN in their lower limbs (e.g., tingling, burning that isn't reported as painful, numbness)
- •Report at least 2 of the following symptoms in their lower limbs (at their worst) as at least 4 out of 10 on a 0 - 10 NRS: hot/burning pain, sharp/shooting pain, numbness, tingling, cramping at visit 1 (i.e., week -1). Use the CIPN Symptom Inventory - week recall form (questions 1-5 ONLY) to assess these symptoms at screening
- •Be willing and able not to start any new analgesic medications or change the dosages of any current analgesic medications (except acetaminophen [Tylenol] or non-steroidal anti-inflammatory drugs [NSAIDs] [i.e., ibuprofen (Advil, Motrin), naproxen (Aleve)]) for the duration of the study
- •Be able to read English (i.e., is not illiterate, can speak English, and is not blind)
- •Have access to a smart phone or device with an Apple or Android operating system that can be used to access the TENS device's application (App) and ability to connect to the internet on a daily basis during the trial
排除标准
- •Have pre-existing neuropathy of any cause documented in their medical record prior to the start of chemotherapy or respond "yes" to the question "Did you have frequent numbness, tingling, sharp/shooting pain, hot/burning pain, or cramping in your feet before you started your chemotherapy?"
- •Have unilateral CIPN symptoms (i.e., symptoms occur on predominantly only one side of the body)
- •Be currently using a TENS device for any other reason
- •Be currently taking, or have taken in the past 3 months, medications known to cause neuropathy in a significant portion of patients
- •Have an acute and symptomatic lower extremity deep vein thrombosis (DVT) (treated DVT with resolution of symptoms is acceptable for enrollment)
- •Lower extremity edema that is 2+ or greater (i.e., slight indentation that takes less than 15 seconds to rebound)
- •Have started a new prescription pain medication or altered dosages of a prescription pain medication within the last 2 weeks
- •Have lower extremity wounds or ulcers
- •Have a cardiac pace maker or defibrillator
- •Have epilepsy
- •Have a leg that is too small or too large for the TENS device to fit securely
- •Have missing lower limbs or amputations
- •Have impaired decision making capacity (i.e., requires a legally authorized representative or health care proxy)
- •Be pregnant or planning to get pregnant before expected completion of the study
结局指标
主要结局
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
时间窗: 6 weeks after the start of intervention
Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy
次要结局
- Effect of TENS on Sharp/Shooting Pain(6 weeks after the start of intervention)
- Effect of TENS on Cramping(6 weeks after the start of intervention)
- Effect of TENS on Numbness(6 weeks after the start of intervention)
- Effect of TENS on Tingling(6 weeks after the start of intervention)
- Effect of TENS on Hot/Burning Pain(6 weeks after the start of intervention)
研究者
Jennifer Gewandter
Assistant Professor
University of Rochester NCORP Research Base