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NCT06822348Recruiting

Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study

Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study (OSTEOCAN2)

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
31 Jan 2025
Start date
31 Aug 2026
Primary completion date
1 Mar 2027
Lead sponsor
Centre Hospitalier Henri Duffaut - Avignon
Diseases
Lung cancer
NCT number
NCT06822348

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 31 Aug 2026 to the primary completion date, 1 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with relapsed cancer already treated with chemotherapy.

Other illness

  • Patient with cardiac arrhythmia.
  • Patient undergoing treatment influencing cardiac rhythm (anti-arrhythmic drugs, beta-blockers, etc.)

Other

  • Patient with unilateral or bilateral vagotomy.

Who the study is looking for

  • Patient with stage 4 lung cancer.
  • WHO stage ≤ to 2.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Coordinator of this site? Confirm its status
AvignonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.