Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Group Type ACTIVE_COMPARATOR

Quality of life assessment

Intervention Type BEHAVIORAL

EORTC FA-12 questionnaire

Anxiety assessment

Intervention Type BEHAVIORAL

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

Heart rate variability assessment

Intervention Type 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).

Osteopathy group

Group Type EXPERIMENTAL

Osteopathic treatment

Intervention Type OTHER

Osteopathic manipulation

Quality of life assessment

Intervention Type BEHAVIORAL

EORTC FA-12 questionnaire

Anxiety assessment

Intervention Type BEHAVIORAL

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

Heart rate variability assessment

Intervention Type 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).

Interventions

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Osteopathic treatment

Osteopathic manipulation

Intervention Type OTHER

Quality of life assessment

EORTC FA-12 questionnaire

Intervention Type BEHAVIORAL

Anxiety assessment

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

Intervention Type BEHAVIORAL

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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No