A Pilot Randomized Sham-Controlled Trial of MC5-A Calmare Therapy (Scrambler Therapy) in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in Pain as Measured by the Modified Brief Pain Index at 28 Days
研究概览
简要总结
The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will relieve chemotherapy induced peripheral neuropathy (CIPN).
Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy machine directs electrical signals across the field to simulate non-pain information.
Based on other studies, we think that we relieve pain with the Scrambler therapy device, but it has not been tested in a setting such as this one. This means that some of the pain relief could be due to placebo effect, or the CIPN pain going away on its own. In this study we want to compare the Scrambler Therapy with the sham therapy (the therapy that does not use the electrical signals). We hope that this study will help us determine if the Scrambler device really helps patients with CIPN.
Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for at least 3 months may be eligible to join this study.
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, Care Provider, 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
- •Men and women, 18 years of age or older with cancer
- •English speakers
- •Lower extremity CIPN neuropathy: Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezimib).
- •Pain or symptoms of lower extremity peripheral neuropathy of >3 month's duration attributed to chemotherapy-induced peripheral neuropathy
- •An average daily pain rating of > 4 out of 10
- •Life expectancy >3 months
- •ECOG Performance Status 0, 1, 2, or 3
- •Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form
排除标准
- •Any of the following: pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.).
- •Use of an investigational agent for pain control concurrently or within the past 30 days
- •History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation
- •Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
- •Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates. (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed)
- •Patients with a history of myocardial infarction or ischemic heart disease within the past six months
- •Patients with history of epilepsy, brain damage, or symptomatic brain metastases
- •Prior celiac plexus block, or other neurolytic pain control treatment
- •Other identified causes of painful parasthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: e.g., carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) that might be responsible for the patient's current neuropathic symptoms
- •Skin conditions such as open sores that would prevent proper application of the electrodes
- •Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
- •Currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin (Neurontin) or pregabalin (Lyrica). Because of data that support that patients do not do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off them prior to study initiation. The study team will provide instructions on how to do this
研究组 & 干预措施
Scrambler Therapy
The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.
干预措施: Scrambler Therapy (Device)
Sham Therapy
The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.
干预措施: Sham Therapy (Device)
结局指标
主要结局
Change in Pain as Measured by the Modified Brief Pain Index at 28 Days
时间窗: Change from baseline to 28 days
To determine the change in pain from day 0 to day 28 (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.
次要结局
- Change in Pain at 2 Months as Measured by the Modified Brief Pain Index(Change from baseline to 2 months)
- Changes in Patient Reported Motor Outcomes at 3 Months(Change from baseline to 3 months)
- Change in Pain at 3 Months as Measured by the Modified Brief Pain Index(Change from baseline to 3 months)
- Changes in Patient Reported Sensory Outcomes at 28 Days(Change from baseline to 28 days)
- Changes in Patient Reported Sensory Outcomes at 2 Months(Change from baseline to 2 months)
- Changes in Patient Reported Sensory Outcomes at 3 Months(Change from baseline to 3 months)
- Changes in Patient Reported Motor Outcomes at 28 Days(Change from baseline to 28 days)
- Changes in Patient Reported Motor Outcomes at 2 Months(Change from baseline to 2 months)
- Number of Patients Who Stopped Using Opioids at 28 Days(28 days post-intervention)
- Number of Patients Who Stopped Using Neuroleptics at 28 Days(28 days post-intervention)