Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Gynecological Cancer Undergoing Curative and Palliative Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Skeletal muscle mass
研究概览
简要总结
This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function, quality of life, fatigue and Inflammatory status on patients with gynecological cancer undergoing palliative anti-cancer Treatment. Furthermore, this study assesses the effect of this combined therapeutic approach within a 3 to 4-week pre-operative study Intervention on the period of hospitalization in gynecological patients undergoing curative anti-cancer Treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients with gynecological cancer undergoing palliative or curative treatment
- •18 years and older
- •ECOG status > 2
排除标准
- •simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months
- •acute cardiovascular events
- •use of anabolic medications
- •severe neurological diseases
- •skin lesions in the area of electrodes
- •energy active metals in body
- •pregnancy
- •acute vein thrombosis
- •rheumatic diseases
- •pregnant and nursing women
- •psychiatric disorders with doubts about legal and cognitive capacity
结局指标
主要结局
Change in Skeletal muscle mass
时间窗: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Period of hospitalization
时间窗: 3-4 week (curative treatment)
Days of Hospital stay after curative surgery
次要结局
- Gastrointestinal toxicity of chemotherapy(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Physical function - Endurance(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Physical function - Isometric muscle strength(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Physical function - Lower limb strength(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Patient-reported performance status(12 weeks (palliative treatment), 3-4 weeks (curative treatment), Total Score ranges from 0-100 with a higher score indicating better performance status)
- Patient-reported Quality of Life (QoL)(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Pain score(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Physical activity(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Patient-reported Fatigue(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Depression score(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
- Inflammatory status(12 weeks (palliative treatment), 3-4 weeks (curative treatment))