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

NCT06822348 — Not applicable, Recruiting, 80 participants, Centre Hospitalier Henri Duffaut - Avignon
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Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study (OSTEOCAN2)

RegistryNCT06822348
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment80 (Estimated)
SponsorCentre Hospitalier Henri Duffaut - Avignon (Other); collaborators: Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA
ConditionsLung Cancer
InterventionsOsteopathic treatment, Quality of life assessment, Anxiety assessment, Heart rate variability assessment (Other, behavioral)
Datesstart 2026-08-31, primary completion 2027-03-01 (estimated), completion 2027-04-01 (estimated), first posted 2025-02-12, last updated 2026-10-21
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Lung Cancer All trials of Osteopathic treatment All trials of Quality of life assessment

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Control groupActive comparatorBehavioral: Quality of life assessment; Behavioral: Anxiety assessment; Other: Heart rate variability assessment
Osteopathy groupExperimentalOther: Osteopathic treatment; Behavioral: Quality of life assessment; Behavioral: Anxiety assessment; Other: Heart rate variability assessment
  • Osteopathic treatment (Other): Osteopathic manipulation
  • Quality of life assessment (Behavioral): EORTC FA-12 questionnaire
  • Anxiety assessment (Behavioral): STAI-Y-A and STAI-Y-B questionnaire assessment
  • Heart rate variability assessment (Other): 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).

+Outcome measures

Primary outcomes

  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: rMSSD (root mean square of successive R-R intervals).

Secondary outcomes

  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: SDNN (standard deviation of all NN intervals, measured in milliseconds).
  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: HF (high frequencies, measured in milliseconds squared).
  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: LF (low frequencies, measured in milliseconds squared).
  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: LF/HF ratio (a low ratio could indicate parasympathetic dominance).
  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: Heart rate deceleration capacity (measured in milliseconds).
  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: Heart rate acceleration capacity (measured in milliseconds).
  • Assessment of heart rate variability. [At baseline and before the first chemotherapy session]: Heart rate (measured in beats per minute).
  • Osteopathic testing of somatic dysfunctions. [Before the first chemotherapy session]: Number of osteopathic vagus nerve dysfunctions.
  • Assessment of quality of life. [At baseline and before the second chemotherapy session]: EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).
  • Anxiety assessment [At baseline]: State-Trait Anxiety Inventory : STAI-Y-B questionnaire (minimum = 20, maximum = 80, higher score means higher level of anxiety)
  • Anxiety assessment [Before the first chemotherapy session]: State-Trait Anxiety Inventory : STAI-Y-A questionnaire (minimum = 20, maximum = 80, higher score means higher level of anxiety)

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

FacilityCityCountryStatus
Centre Hospitalier d'Avignon, Hôpital Henri DuffautAvignonFranceRecruiting

+Investigators