NCT02991677进行中（未招募）不适用
Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sensory pain
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with cancer, stage I-IV
- •History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents
- •Completion of chemotherapy > 6 months < 1 year
- •Ability to walk on a treadmill
- •Medical clearance from oncologist or primary care provider
- •Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3 (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering with activities of daily living (ADLs), 3-severe symptoms interfering with ADL, 4-disabling, and 5 is death)
- •Score on Neuropathic Pain Scale >1
- •Age 21-70
排除标准
- •Denial of CIPN
- •Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes)
- •Coronary artery disease
- •History of >1 chemotherapy regimen
- •Musculoskeletal conditions which preclude participation in an exercise training program
- •Pregnancy
- •Regular exerciser, defined as >90 minutes per week of aerobic exercise and any resistive training
结局指标
主要结局
Sensory pain
时间窗: 13 weeks
Thermal, mechanical, and vibration sensation by quantitative sensory testing
次要结局
- Nerve fiber density(13 weeks)
研究者
Alice S. Ryan, PhD
Professor
Baltimore VA Medical Center
研究点 (2)
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