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NCT Number: NCT06822348

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, 84000, France

Location contact

Malek Zoghlami, MD

SUB_INVESTIGATOR

Marilyne Grinand, PhD

CONTACT

[email protected]

(+33)0432759392

Pierrick Martinez, Osteopath

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    rMSSD (root mean square of successive R-R intervals).

Secondary outcomes

  1. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    SDNN (standard deviation of all NN intervals, measured in milliseconds).

  2. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    HF (high frequencies, measured in milliseconds squared).

  3. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    LF (low frequencies, measured in milliseconds squared).

  4. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    LF/HF ratio (a low ratio could indicate parasympathetic dominance).

  5. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    Heart rate deceleration capacity (measured in milliseconds).

  6. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    Heart rate acceleration capacity (measured in milliseconds).

  7. Assessment of heart rate variability.

    Time frame: At baseline and before the first chemotherapy session

    Heart rate (measured in beats per minute).

  8. Osteopathic testing of somatic dysfunctions.

    Time frame: Before the first chemotherapy session

    Number of osteopathic vagus nerve dysfunctions.

  9. Assessment of quality of life.

    Time frame: At baseline and before the second chemotherapy session

    EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).

  10. Anxiety assessment

    Time frame: At baseline

    State-Trait Anxiety Inventory : STAI-Y-B questionnaire (minimum = 20, maximum = 80, higher score means higher level of anxiety)

  11. Anxiety assessment

    Time frame: Before the first chemotherapy session

    State-Trait Anxiety Inventory : STAI-Y-A questionnaire (minimum = 20, maximum = 80, higher score means higher level of anxiety)

Study contacts

Contact information is provided by the study sponsor or research team.

Marilyne Grinand, PhD

CONTACT

[email protected]

(+33)432759392

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Duffaut - Avignon

Other

Collaborators

  • Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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