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

NCT06822348 | Not Yet Recruiting

• 1 other identifier: OSTEOCAN2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Cancer

Keywords

osteopathy; heart rate variability; quality of life

Outcome Measures

Primary Outcomes (1)

• Assessment of heart rate variability.

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

  At baseline and before the first chemotherapy session

Secondary Outcomes (11)

• Assessment of heart rate variability.

  At baseline and before the first chemotherapy session

• Assessment of heart rate variability.

  At baseline and before the first chemotherapy session

• Assessment of heart rate variability.

  At baseline and before the first chemotherapy session

• Assessment of heart rate variability.

  At baseline and before the first chemotherapy session

• Assessment of heart rate variability.

  At baseline and before the first chemotherapy session

Study Arms (2)

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

Interventions

Osteopathic treatment OTHER

Osteopathic manipulation

Osteopathy group

Quality of life assessment BEHAVIORAL

EORTC FA-12 questionnaire

Control group; Osteopathy group

Anxiety assessment BEHAVIORAL

STAI-Y-A and STAI-Y-B questionnaire assessment

Control group; Osteopathy group

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).

Control group; Osteopathy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Formation en Ostéopathie du Grand Avignon - IFO-GA: collaborator
• Centre Hospitalier Henri Duffaut - Avignon: lead

Study Sites (1)

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, 84000, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Pierrick Martinez, Osteopath

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyne Grinand, PhD

CONTACT

(+33)432759392; grinand.marilyne@ch-avignon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 80 patients will be included, these patients will be randomized into two groups.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 12, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

FR (1)