NMES for Patients With NSCLC Receiving Palliative Chemotherapy. Is Neuromuscular Electrical Stimulation an Acceptable and Feasible Supportive Therapy for Patients With Non-Small Cell Lung Cancer Receiving Palliative Chemotherapy?
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Adherence to neuromuscular electrical stimulation (NMES) therapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy can lead to a loss of leg muscle strength. Neuromuscular electrical stimulation may improve muscle strength and quality of life. It is not yet known whether chemotherapy given together with neuromuscular electrical stimulation is more effective than chemotherapy alone in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying first-line chemotherapy given together with neuromuscular electrical stimulation to see how well it works compared with chemotherapy alone in treating patients with non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the feasibility of first-line palliative chemotherapy alone versus palliative chemotherapy in combination with neuromuscular electrical stimulation (NMES) in patients with non-small cell lung cancer.
Secondary
- To determine if NMES is safe for patients undergoing palliative chemotherapy.
- To determine to what extent 3 or 4 courses of palliative chemotherapy impact leg muscle strength, body composition, and physical activity levels and if the use of NMES influence these changes.
- To determine the rate of recovery or decline in leg muscle strength, body composition, and physical activity levels following completion of 3 or 4 courses of palliative chemotherapy and if the use of NMES influences these changes.
- To assess patient attitudes to the use of NMES during palliative chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Scheduled to receive 3 or 4 courses of first-line palliative chemotherapy
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •Not pregnant or nursing
- •Able to use neuromuscular electrical stimulation device
- •No implanted cardiac pacemaker
- •No epilepsy
- •No spinal cord pathology
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Adherence to neuromuscular electrical stimulation (NMES) therapy
次要结局
- Safety of NMES
- Quadriceps muscle strength
- Body composition
- Physical activity level
- Nutritional intake
- Fatigue
- Quality of life using the EORTC-C30 and LC-13 questionnaire
- Overall objective clinical response to chemotherapy