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

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: Lung Cancer
• Intervention / Treatment: Behavioral: Quality of life assessment; Behavioral: Anxiety assessment; Other: Heart rate variability assessment; Other: Osteopathic treatment

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyne Grinand, PhD; Phone Number: (+33)432759392; Email: grinand.marilyne@ch-avignon.fr

Study Locations

• France
  • Avignon, France, 84000
    • Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
    • Contact: Marilyne Grinand, PhD; Phone Number: (+33)0432759392; Email: grinand.marilyne@ch-avignon.fr
    • Principal Investigator: Pierrick Martinez, Osteopath
    • Sub-Investigator: Malek Zoghlami, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

• 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

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: quality of life; heart rate variability; osteopathy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations; Manipulation, Osteopathic
• 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