Heart Rate Variability, Vagus Nerve and Cancer

Study Overview
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Brief Summary
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In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. But, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy. Several studies showed indirect interaction between vagus nerve and cancer. Firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. Secondly, vagus nerve stimulation increases Heart Rate Variability (HRV). Moreover, a higher HRV is associated with an improvement of vital prognosis in cancer patients. Vagus nerve could be stimulated by noninvasive osteopathic manipulations. This prospective, monocentric and randomized study is a collaboration between the Centre Hospitalier d'Avignon and the Institut de Formation en Ostéopathie du Grand Avignon. It focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. Indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on HRV in patients with lung cancer, colorectal cancer, Non Hodgkin Lymphoma or Multiple Myeloma. More specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of HRV associated with a decrease of systemic inflammation and an improvement of patient's quality of life.

Official Title
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Effects of Vagus Nerve Osteopathic Stimulations on Heart Rate Variability of Cancer Patients

Conditions
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Lung Cancer, Colorectal Cancer, Multiple Myeloma, Non Hodgkin Lymphoma

Intervention / Treatment
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* Other: Osteopathic intervention
* Biological: CRP assessment
* Behavioral: QLQ-C30 questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with lung cancer or colorectal cancer or Non Hodgkin Lymphoma or Multiple Myeloma (Stade I à IV) No previous treatment HRV < 70 ms No osteopathic contraindication Exclusion Criteria: Vagotomy Heart arrhythmia Cancer recurrence Consumption of coffee or tabac within 2 hours prior osteopathic treatment Consumption of alcohol within 24 hours prior osteopathic treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For each cancer type, 30 patients will be included. These patients will be randomized into two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients will receive only caner treatment. No osteopathic treatment. | Biological: CRP assessment<br>* Blood CRP will be assessed during trial<br>Behavioral: QLQ-C30 questionnaire<br>* Completion of QLQ-C30<br>|
| Experimental: Osteopathic intervention<br>Patients will receive cancer treatment associated with osteopathic intervention | Other: Osteopathic intervention<br>* Nerve vagus stimulation<br>Biological: CRP assessment<br>* Blood CRP will be assessed during trial<br>Behavioral: QLQ-C30 questionnaire<br>* Completion of QLQ-C30<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Heart Rate Variability measured by SDNN (Standard Deviation of all NN intervals) from baseline to the end of osteopathic treatment | To assess the effect of vagus nerve osteopathic stimulations on Heart Rate Variability | up to 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of C-Reactive Protein | To assess the effect of vagus nerve osteopathic stimulations on systemic inflammatory | up to 84 days | 
| Time to definitive improvement in global health status / QoL | To assess the effect of vagus nerve osteopathic stimulations on health related quality of life | up to 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Vagus nerve stimulation, Heart rate variability, Osteopathy