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

January 8, 2026 updated by: Centre Hospitalier Henri Duffaut - Avignon

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Avignon, France, 84000
        • Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
        • Contact:
        • Principal Investigator:
          • Pierrick Martinez, Osteopath
        • Sub-Investigator:
          • Malek Zoghlami, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Behavioral: Quality of life assessment
EORTC FA-12 questionnaire
Behavioral: Anxiety assessment
STAI-Y-A and STAI-Y-B questionnaire assessment
Other: Heart rate variability 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).
Experimental: Osteopathy group
Behavioral: Quality of life assessment
EORTC FA-12 questionnaire
Behavioral: Anxiety assessment
STAI-Y-A and STAI-Y-B questionnaire assessment
Other: Heart rate variability 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).
Other: Osteopathic treatment
Osteopathic manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of heart rate variability.
Time Frame: At baseline and before the first chemotherapy session
rMSSD (root mean square of successive R-R intervals).
At baseline and before the first chemotherapy session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time Frame: At baseline and before the first chemotherapy session
HF (high frequencies, measured in milliseconds squared).
At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time Frame: At baseline and before the first chemotherapy session
LF (low frequencies, measured in milliseconds squared).
At baseline and before the first chemotherapy session
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).
At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time Frame: At baseline and before the first chemotherapy session
Heart rate deceleration capacity (measured in milliseconds).
At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time Frame: At baseline and before the first chemotherapy session
Heart rate acceleration capacity (measured in milliseconds).
At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time Frame: At baseline and before the first chemotherapy session
Heart rate (measured in beats per minute).
At baseline and before the first chemotherapy session
Osteopathic testing of somatic dysfunctions.
Time Frame: Before the first chemotherapy session
Number of osteopathic vagus nerve dysfunctions.
Before the first chemotherapy session
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).
At baseline and before the second chemotherapy session
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)
At baseline
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)
Before the first chemotherapy session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Henri Duffaut - Avignon

Collaborators

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

Investigators

  • Principal Investigator: Pierrick Martinez, Osteopath, Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSTEOCAN2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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