A Randomized, Single-Blind, Sham-Controlled Study of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in participant-reported pain
研究概览
简要总结
This research study is for people who have a condition called chemotherapy-induced peripheral neuropathy (CIPN). This condition develops as a result of receiving medication(s) to treat cancer, particularly chemotherapy. CIPN is characterized by pain, numbness, tingling or burning sensations, typically in the hands and feet of people. These symptoms can lead to physical suffering, limited ability to perform daily activities, and low quality of life. One of the ways to treat CIPN is using a device called Scrambler Therapy. Scrambler Therapy was approved by the Food and Drug Administration (FDA) in 2009 as a treatment for CIPN. The treatment involves electrical signals passing through wires attached to parts of the body via adhesive tabs near where symptoms of CIPN are experienced. A standard treatment course consists of 10 daily sessions lasting about one hour each. The purpose of this study is to determine the effect of a 10-day course of Scrambler Therapy on symptoms of chemotherapy-induced peripheral neuropathy, day-to-day activities, overall quality of life, and use of pain medications. Participants will be randomly assigned to one of two groups. One group will receive Scrambler Therapy. The other group will not receive it. Participants will not know which group they were in until after treatment has completed. Participants in the group who did not receive Scrambler Therapy will have the opportunity to receive it after one month. Participants will be in this research study about 12 to 14 months.
详细描述
Neuropathy is damage or disease affecting the somatosensory nervous system. It can result in pain, numbness and other feelings of tingling or burning on the skin. Neuropathic pain often does not go away for a long time, which can negatively impact quality of life. Even though neuropathic pain comes from the nervous system, it is often managed with medications.
In recent years, Scrambler Therapy (ST) has come up as a way to treat neuropathic pain that does not use medications. ST was approved by the FDA in 2009 to treat neuropathic pain. It works by replacing or overriding pain signals and rewires the way that people may perceive pain. It was originally designed to treat cancer pain. A standard course of ST consists of ten daily sessions over two consecutive weeks. Treatment may stop early if participants no longer report feeling neuropathic pain.
Previous research on the effects of ST for neuropathic pain have shown positive findings with very few participants reporting negative side effects of ST treatment. However, there are some limitations of ST, including the time and cost of the treatment, limited availability of ST, and the necessary skills needed to administer it.
ST is a promising solution to pain caused by CIPN. CIPN occurs in 30-40% of people treated with chemotherapy. CIPN can sometimes cause interruptions in cancer treatment and negatively impact quality of life. The amount of people with CIPN may also rise as more people with cancer live longer. Due to this, it is important to explore ST as a treatment for CIPN. This study aims to investigate the short-term and long-term impacts of ST as an alternative to medication treatments for CIPN.
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
- Single (Participant)
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
- •Adults with CIPN-related pain for at least three months duration, and for which the participant wants intervention
- •At least three months from the last dose of neurotoxic cancer-directed drug
- •No plan (at the time of study enrollment) for additional neurotoxic cancer-directed therapies for at least five months after trial enrollment
- •Pain rated ≥ four out of 10 in severity (0-10 pain scale) during the seven days prior to enrollment
- •> Six-month life expectancy
- •Able to complete questionnaires by themselves or with assistance
- •Able to provide informed written consent
- •ECOG Performance Status score ≥ two
- •Not currently enrolled in another research study for pain or neuropathy
排除标准
- •Pregnant or nursing
- •An operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and/or medical monitoring device
- •History of myocardial infarction or ischemic heart disease within six months of trial enrollment
- •History of epilepsy, brain damage resulting in seizure activity, or use of anticonvulsants for seizure
- •Skin conditions such as open sores that will prevent proper application of electrodes
- •Unwillingness or inability to wean and discontinue gabapentin or pregabalin prior to the start of ST
- •History of symptomatic peripheral neuropathy prior to receiving neurotoxic chemotherapy
- •Prior treatment with Scrambler Therapy
- •The presence of chronic regional pain syndrome (CRPS) in the scrambler therapy treatment area.
研究组 & 干预措施
Sham Scrambler Therapy
干预措施: Sham/No Intervention (Other)
Scrambler Therapy
干预措施: Scrambler Therapy (Device)
结局指标
主要结局
Change in participant-reported pain
时间窗: Baseline, end of treatment (up to 14 days)
Participant-reported pain is measured by the Severity of Neuropathic Symptoms, in which participants rank their pain on a scale of 0 (Not at All) to 10 (Severe). Higher scores indicate greater pain symptoms.
次要结局
- Change in participant-reported non-pain neuropathic symptoms(Baseline, end of treatment (up to 14 days))
- Change in functional status(Baseline, end of treatment (up to 14 days))
- Change in quality of life(Baseline, end of treatment (up to 14 days))
- Change in participant-perceived treatment efficacy(Baseline, end of treatment (up to 14 days))