The Influence of Stochastic Modulated Vibrations on the Autonomic Nervous System of Breast Cancer Patients During Radiotherapy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- change in Heart Rate Variability (HRV)
研究概览
简要总结
The aim of this research is to study the influence of stochastic modulated vibrations on the autonomic nervous system of breast cancer patients during radiation therapy
详细描述
Since it is well known that breast cancer patients experience an important load of stress from diagnosis through treatment and throughout cancer survivorship (fear of cancer recurrence), this study focusses on activation the parasympathetic nervous system and making patients as comfortable as possible during treatment. The scope of this study is based on previous research, that has shown that controlling physical and psychological complications during treatment may have a positive (preventive) effect on late term and long-term quality of life and survival outcomes. Breast cancer patients will receive andullation during their irradiation period. The primary outcome measure of the autonomic nervous system is vagal nerve activity, a modulator of the parasympathetic nervous system. Secondary outcome measures are stress, pain and lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Histological proven breast cancer, following breast cancer surgery
- •Starting with adjuvant radiation therapy for 3 weeks
- •Minimum 18 years
- •Medical record available and complete
- •Supine lying on mattress for 20 minutes is possible
- •Dutch, French or English
排除标准
- •Severe neurological, orthopaedic or rheumatic disorders
- •Cardiac disorders
- •Early or synchronous malignancy
- •Pregnancy or lactation
- •Persons suffering from depression or illnesses which influence the mental health or wellbeing
研究组 & 干预措施
Intervention
A 3 week intervention with Andullation will be performed, 3 times a week for 20 minutes after completion of the radiotherapy session
干预措施: Andullation (Device)
Control
This group will follow the same intervention protocol, but without the application of the Andullation technology
干预措施: Placebo (Other)
结局指标
主要结局
change in Heart Rate Variability (HRV)
时间窗: through study completion, an average of 6 weeks
a marker of the activity of your autonomic nervous system.
次要结局
- change in Distress Thermometer(through study completion, an average of 6 weeks)
- change in Brief Pain Inventory(through study completion, an average of 6 weeks)
- change in Numeric Pain Rating Scale(through study completion, an average of 6 weeks)
- change in Perometer results(through study completion, an average of 6 weeks)
- change in Bioimpedance spectroscopy(through study completion, an average of 6 weeks)
- change in European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30)(through study completion, an average of 6 weeks)
- change in European Organization for Research and Treatment of Cancer 23-item quality of life questionnaire (EORTC QLQ BR23)(through study completion, an average of 6 weeks)
- change in Pittsburgh Sleep Quality Index(through study completion, an average of 6 weeks)
- change in Insomnia Severity Index(through study completion, an average of 6 weeks)
研究者
Nele
principal investigator
Universitair Ziekenhuis Brussel