Osteopathic care for heart rate variability in advanced lung cancer patients
Official title: Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study (OSTEOCAN2)
Run by Centre Hospitalier Henri Duffaut - Avignon · NCT06822348 · Data updated 2026-11-12
This pilot test checks whether osteopathic manipulation can influence heart rate variability in people with stage 4 lung cancer who are receiving chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Centre Hospitalier Henri Duffaut - Avignon Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Avignon) |
| Status | Recruiting |
| Started | August 31, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT06822348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with stage 4 lung cancer, starting chemotherapy, and meeting specific heart rhythm and symptom criteria.
✕Probably not a fit
Patients with arrhythmias, vagotomy, or other conditions that contraindicate manipulation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized study explores if osteopathic manipulation can affect heart rate variability and quality of life in patients with advanced lung cancer undergoing chemotherapy. Participants are adults with stage 4 disease, evaluated for heart rhythm metrics and well-being, and randomly assigned to receive osteopathic treatment plus standard care or standard care alone. The study measures rMSSD and SDNN from heart rate data, along with quality of life and anxiety assessments, to see if the osteopathic approach yields any short-term changes. The trial acknowledges potential risks from manual therapy but excludes those with conditions that could be worsened by manipulation. Results could inform whether osteopathic care is a feasible adjunct for symptom management in this population.
Why it matters
Potential benefit: If successful, osteopathic treatment could improve heart rate variability and quality of life for patients during chemotherapy.
How similar studies have gone: Previous work has suggested links between the vagus nerve and systemic responses, but robust evidence for osteopathic manipulation in cancer care is limited, making this an exploratory study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon, France Recruiting
Study contacts
- Principal investigator: Pierrick Martinez, Osteopath — Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA
- Study coordinator: Marilyne Grinand, PhD
- Email: grinand.marilyne@ch-avignon.fr
- Phone: (+33)432759392
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.