An interventional study of Osteopathic treatment and Quality of life assessment in Lung Cancer, sponsored by Centre Hospitalier Henri Duffaut - Avignon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Centre Hospitalier Henri Duffaut - Avignon · Not applicable, Interventional, and Supportive care
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Centre Hospitalier Henri Duffaut - Avignon is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Quality of life assessment · Behavioral: Anxiety assessment · Other: Heart rate variability assessment
Other: Osteopathic treatment · Behavioral: Quality of life assessment · Behavioral: Anxiety assessment · Other: Heart rate variability assessment
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).
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Henri Duffaut - Avignon