NCT01196442已完成不适用
An Expanded Trial of MC5-A Calmare Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy Including Pain and Numbness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in Pain Score From Day 1 to Day 10
研究概览
简要总结
RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy in treating chronic pain and numbness caused by chemotherapy in patients with cancer.
详细描述
OBJECTIVES:
I. To evaluate the effect of MC5-A on pain symptoms both immediately and over time.
II. To evaluate the effect of Calmare therapy on other non-pain symptoms. III. To evaluate the effect of MC5-A on daily opioid and other pain medication use.
OUTLINE: Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days. After completion of study treatment, patients are followed up for 3 months.
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
- •CIPN neuropathy: received, or currently receiving, 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 bortezomib)
- •Pain or symptoms of peripheral neuropathy of >= 1 months duration attributed to chemotherapy-induced peripheral neuropathy
- •OR pain of the other types including chemotherapy-induced peripheral neuropathy, numbness predominant; post mastectomy pain; post surgical pain; post herpetic neuropathy; post radiation pain; other (vertebral compression, fracture, miscellaneous)
- •The pain must have been stable for at least 2 weeks
- •An average daily pain rating of >= 5 out of 10, using the pain numerical rating scale (NRS: 0 is no pain and 10 is worst pain possible); or numbness that bothers the patient at least "a little bit" on the CIPN-20
- •Life expectancy >= 3 months
- •ECOG performance status 0, 1, or 2
排除标准
- •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 =< 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, 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, use of anti-convulsants, symptomatic brain metastases
- •Prior celiac plexus block, or other neurolytic pain control treatment within 4 weeks
- •Other identified causes of painful paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy)
- •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
结局指标
主要结局
Change in Pain Score From Day 1 to Day 10
时间窗: From day 1 to day 10
Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference)
次要结局
- Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1(Day 1)
- Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics(From day 1 to day 30)
- Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10(Day 10)
- Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1(month 1)
- Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2(month 2)
- Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3(Month 3)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by ChemotherapyChemotherapeutic Agent ToxicityNeurotoxicityPainUnspecified Adult Solid Tumor, Protocol SpecificPeripheral NeuropathyNCT00952848Virginia Commonwealth University18
已完成
不适用
Cranial Electrotherapy Stimulation in the Treatment of Migraine HeadachesMigraineNCT01265797University of Toledo Health Science Campus68
已完成
2 期
Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic NeuropathyPainful Diabetic NeuropathyNCT00337324IRCCS San Raffaele38
已完成
不适用
Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?HabituationNCT03237650Ruhr University of Bochum33
进行中（未招募）
不适用
Promoting Healing of Nerves Through Electrical StimulationNerve CompressionUlnar NeuropathiesNerve InjuryCubital Tunnel SyndromeNCT04662320Checkpoint Surgical Inc.100