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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Osteopathic manipulation
EORTC FA-12 questionnaire
STAI-Y-A and STAI-Y-B questionnaire assessment
rMSSD (root mean square of successive R-R intervals), SDNN (standard deviation of all NN intervals), HF (high frequencies), LF (low frequencies), LF/HF ratio, Heart rate deceleration capacity, Heart rate acceleration capacity, Heart rate (bpm).
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon, France
Assessment of heart rate variability.
rMSSD (root mean square of successive R-R intervals).
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
SDNN (standard deviation of all NN intervals, measured in milliseconds).
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
HF (high frequencies, measured in milliseconds squared).
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
LF (low frequencies, measured in milliseconds squared).
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
LF/HF ratio (a low ratio could indicate parasympathetic dominance).
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Heart rate deceleration capacity (measured in milliseconds).
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Heart rate acceleration capacity (measured in milliseconds).
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Heart rate (measured in beats per minute).
Time frame: At baseline and before the first chemotherapy session
Osteopathic testing of somatic dysfunctions.
Number of osteopathic vagus nerve dysfunctions.
Time frame: Before the first chemotherapy session
Assessment of quality of life.
EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).
Time frame: At baseline and before the second chemotherapy session
Anxiety assessment
State-Trait Anxiety Inventory : STAI-Y-B questionnaire (minimum = 20, maximum = 80, higher score means higher level of anxiety)
Time frame: At baseline
Anxiety assessment
State-Trait Anxiety Inventory : STAI-Y-A questionnaire (minimum = 20, maximum = 80, higher score means higher level of anxiety)
Time frame: Before the first chemotherapy session
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