Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study (OSTEOCAN2)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Assessment of heart rate variability.
研究概览
简要总结
In France, the number of new cancer cases each year is rising steadily, while the number of deaths, although falling, is still around 157,000, including 23,000 from lung cancer alone. According to the French National Cancer Institute, there are three main methods of treating cancer: chemotherapy, radiotherapy and surgery. In recent years, new therapies have been developed, notably with the advent of immunotherapy and targeted therapies. On the other hand, although non-medical interventions (NMIs) such as osteopathy are recognized as improving the quality of life of cancer patients, there has been little research into their contribution when combined with conventional therapies.
Studies have shown a link between the vagus nerve and cancer. Through its actions, the vagus nerve regulates homeostasis and immunity at local and regional levels, reducing systemic inflammation but maintaining local inflammation, which has an anti-tumour effect. At the same time, vagus nerve stimulation increases heart rate variability, which, when increased, is associated with improved vital prognosis in cancer patients. This stimulation can be achieved using a number of common, non-invasive osteopathic techniques.
To date, no study has shown an objective and definitive link between vagus nerve stimulation and improved vital prognosis. However, several studies show that vagus nerve activity may be related to prognosis in cancer patients through regulation of HRV and possibly inflammation. Osteopathic manipulation to stimulate the vagus nerve could therefore have an effect on HRV. Improved HRV could therefore indirectly improve the prognosis of cancer patients. The first step is to test this clinical hypothesis: does osteopathic manipulation stimulate the vagus nerve in cancer patients? This will be done by measuring heart rate variability using rMSSD, the metric most representative of vagal tone.
This randomized single-center pilot study will investigate the short-term effect of vagus nerve stimulation using osteopathic techniques on heart rate variability in lung cancer patients. Our hypothesis is that stimulation of the vagus nerve by gentle, non-invasive osteopathic manipulation would increase vagal tone and therefore improve HRV and quality of life in the short term, but also reduce anxiety experienced at the time of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with stage 4 lung cancer.
- •WHO stage ≤ to
- •Dyspnea grade ≤ 2 on the mMRC scale (modified Medical Research Council)
- •Patient undergoing chemotherapy for the first time
- •Patient with less than 5% artifact rate during rMSSD measurement.
- •Patient with SDNN less than 70 ms.
- •Voluntary patient who has signed the informed consent form.
- •No contraindications to osteopathic manipulation.
排除标准
- •Patient with unilateral or bilateral vagotomy.
- •Patient with cardiac arrhythmia.
- •Patient undergoing treatment influencing cardiac rhythm (anti-arrhythmic drugs, beta-blockers, etc.)
- •Patient with relapsed cancer already treated with chemotherapy.
研究组 & 干预措施
Control group
干预措施: Quality of life assessment (Behavioral)
Control group
干预措施: Anxiety assessment (Behavioral)
Control group
干预措施: Heart rate variability assessment (Other)
Osteopathy group
干预措施: Osteopathic treatment (Other)
Osteopathy group
干预措施: Quality of life assessment (Behavioral)
Osteopathy group
干预措施: Anxiety assessment (Behavioral)
Osteopathy group
干预措施: Heart rate variability assessment (Other)
结局指标
主要结局
Assessment of heart rate variability.
时间窗: At baseline and before the first chemotherapy session
rMSSD (root mean square of successive R-R intervals).
次要结局
- Assessment of heart rate variability.(At baseline and before the first chemotherapy session)
- Anxiety assessment(At baseline)
- Osteopathic testing of somatic dysfunctions.(Before the first chemotherapy session)
- Assessment of quality of life.(At baseline and before the second chemotherapy session)
- Anxiety assessment(Before the first chemotherapy session)
