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

Official title

Short-term Effects of Osteopathic Manipulations on Heart Rate Variability in Lung Cancer Patients - A Randomized Pilot Study (OSTEOCAN2)

Overview

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.

Interventions

• Other Osteopathic treatment
  Osteopathic manipulation
• 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).

Primary outcome measures

• Assessment of heart rate variability. [Time frame: At baseline and before the first chemotherapy session]

Secondary outcome measures (11)

• 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Centre Hospitalier d'Avignon, Hôpital Henri Duffaut — Avignon

Identifiers

NCT: NCT06822348 · OSTEOCAN2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗