NCT00952848已完成2 期
The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Change in Pain Score
研究概览
简要总结
RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.
PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy.
详细描述
OBJECTIVES:
Primary
- To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%.
Secondary
- To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales.
- To evaluate the effect of MC5-A therapy on overall quality of life.
- To evaluate the effect of MC5-A therapy on other pain drugs used.
- To evaluate the toxicities of MC5-A therapy.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Chemotherapy-induced peripheral neuropathy (CIPN) meeting the following criteria:
- •More than 4 weeks since prior neurotoxic chemotherapy including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cis-platinum, oxaliplatin), vinca-alkaloids (e.g., vincristine, vinblastine, or vinorelbine), or proteosome inhibitors (e.g., bortezomib)
- •Pain or symptoms of peripheral neuropathy for ≥ 1 month attributed to CIPN
- •Pain stable for ≥ 2 weeks
- •Average daily pain rating of ≥ 5 out of 10 using the pain numerical rating scale (0 is no pain and 10 is worst pain possible)
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of an allergic reaction or intolerance to transcutaneous electronic nerve stimulation
- •No pacemaker or implantable drug-delivery system (e.g., Medtronic Synchromed)
- •No heart stent or vena cava clips
- •No history of epilepsy or brain damage
- •No other identified causes of painful paresthesias existing before chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology [e.g., B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism, hypothyroidism, inherited neuropathy, etc.])
- •No skin conditions (e.g., open sores) that would prevent proper application of the electrodes
- •No other medical or other conditions that, in the opinion of the investigators, might compromise the objectives of the study
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 30 days since prior and no concurrent investigational agents for pain control
- •More than 4 weeks since prior and no concurrent celiac plexus block or other neurolytic pain control treatment
- •No prior or concurrent anti-convulsants
- •No concurrent neurotoxic or potentially neurotoxic chemotherapy
- •Concurrent pain treatments allowed provided the following criteria are met:
- •Pain is not satisfactorily controlled
- •Dose of the other medication has been stable for ≥ 4 weeks
排除标准
- 未提供
研究组 & 干预措施
MC5-A Scramble instrument
Experimental
Treatment of chronic neuropathic pain with the MC5-A device
干预措施: questionnaire administration (Other)
MC5-A Scramble instrument
Experimental
Treatment of chronic neuropathic pain with the MC5-A device
干预措施: Sensory Neuropathy Scale instrument (Other)
MC5-A Scramble instrument
Experimental
Treatment of chronic neuropathic pain with the MC5-A device
干预措施: Quality of Life instrument (Other)
MC5-A Scramble instrument
Experimental
Treatment of chronic neuropathic pain with the MC5-A device
干预措施: MC5-A Scrambler device (Device)
结局指标
主要结局
Change in Pain Score
时间窗: 15 days
Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe)
次要结局
- Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy(2 weeks)
- Effect of MC5-A on Pain and Neuropathy(2 weeks)
- Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument(2 weeks)
研究者
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