Lung CancerNCT06822348
Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study
A study testing Osteopathic treatment, Quality of life assessment and Anxiety assessment in people with Lung Cancer, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Osteopathic treatment, Quality of life assessment and Anxiety assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon, 84000
Marilyne Grinand, PhD, (+33)0432759392, grinand.marilyne@ch-avignon.fr
Pierrick Martinez, Osteopath
About this study
Official title: 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.
Read more
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.
- Conditions
- Lung Cancer
- Being tested
- Osteopathic treatment, Quality of life assessment, Anxiety assessment, Heart rate variability assessment
- Keywords
- osteopathy, heart rate variability, quality of life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentOther
Osteopathic manipulation
Quality of life assessmentBehavioural
EORTC FA-12 questionnaire
Anxiety assessmentBehavioural
STAI-Y-A and STAI-Y-B questionnaire assessment
Heart rate variability assessmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Behavioral: Quality of life assessment; Behavioral: Anxiety assessment; Other: Heart rate variability assessment |
| Osteopathy group | Experimental | Not described Receives: Other: Osteopathic treatment; Behavioral: Quality of life assessment; Behavioral: Anxiety assessment; Other: Heart rate variability assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of heart rate variability.
rMSSD (root mean square of successive R-R intervals).
Measured: At baseline and before the first chemotherapy session
Secondary outcomes (11)
Assessment of heart rate variability.
SDNN (standard deviation of all NN intervals, measured in milliseconds).
Measured: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
HF (high frequencies, measured in milliseconds squared).
Measured: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
LF (low frequencies, measured in milliseconds squared).
Measured: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
LF/HF ratio (a low ratio could indicate parasympathetic dominance).
Measured: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Heart rate deceleration capacity (measured in milliseconds).
Measured: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Heart rate acceleration capacity (measured in milliseconds).
Measured: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Heart rate (measured in beats per minute).
Measured: At baseline and before the first chemotherapy session
Osteopathic testing of somatic dysfunctions.
Number of osteopathic vagus nerve dysfunctions.
Measured: Before the first chemotherapy session
Assessment of quality of life.
EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).
Measured: 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)
Measured: At baseline
Anxiety assessment
State-Trait Anxiety Inventory : STAI-Y-A questionnaire (minimum = 20, maximum = 80, higher score means higher level of anxiety)
Measured: Before the first chemotherapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start31 Aug 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 patients will be included, these patients will be randomized into two groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA
- Responsible party
- Sponsor
- Investigators
- Pierrick Martinez, Osteopath, Principal investigator, Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822348
- Sponsor's protocol ID
- OSTEOCAN2
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study (OSTEOCAN2)
- ClinicalTrials.gov ID
- NCT06822348
- Acronym / sponsor ID
- OSTEOCAN2
- Conditions
- Lung Cancer
- Keywords
- osteopathy, heart rate variability, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri Duffaut - AvignonUniversity, hospital or other
- Collaborators
- Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 80 patients will be included, these patients will be randomized into two groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Quality of life assessment, Behavioral: Anxiety assessment, Other: Heart rate variability assessment |
| Osteopathy group | Experimental | Other: Osteopathic treatment, Behavioral: Quality of life assessment, Behavioral: Anxiety assessment, Other: Heart rate variability assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic treatmentOsteopathic manipulation | Other | Osteopathy group |
| Quality of life assessmentEORTC FA-12 questionnaire | Behavioural | Control group, Osteopathy group |
| Anxiety assessmentSTAI-Y-A and STAI-Y-B questionnaire assessment | Behavioural | Control group, Osteopathy group |
| Heart rate variability assessmentrMSSD (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 | Control group, Osteopathy group |
Primary outcome
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
rMSSD (root mean square of successive R-R intervals).
11 secondary outcomes
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
Assessment of heart rate variability.
Time frame: At baseline and before the first chemotherapy session
Osteopathic testing of somatic dysfunctions.
Time frame: Before the first chemotherapy session
Assessment of quality of life.
Time frame: At baseline and before the second chemotherapy session
Anxiety assessment
Time frame: At baseline
Anxiety assessment
Time frame: Before the first chemotherapy session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierrick Martinez, Osteopath principal investigator
Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment, Quality of life assessment and Anxiety assessment in people with Lung Cancer, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marilyne Grinand, PhD ((+33)432759392, grinand.marilyne@ch-avignon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of heart rate variability. (time frame: At baseline and before the first chemotherapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.