Heart Rate Variability, Vagus Nerve and Cancer
Effects of Vagus Nerve Osteopathic Stimulations on Heart Rate Variability of Cancer Patients
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Avignon, France, 84000
- Centre Hospitalier Henri Duffaut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Patients will receive only caner treatment.
No osteopathic treatment.
|
Blood CRP will be assessed during trial
Completion of QLQ-C30
|
|
Experimental: Osteopathic intervention
Patients will receive cancer treatment associated with osteopathic intervention
|
Blood CRP will be assessed during trial
Completion of QLQ-C30
Nerve vagus stimulation
|
What is the study measuring?
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
Time Frame: up to 84 days
|
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
Time Frame: up to 84 days
|
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
Time Frame: up to 84 days
|
To assess the effect of vagus nerve osteopathic stimulations on health related quality of life
|
up to 84 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Borhane SLAMA, MD, Centre Hospitalier Henri Duffaut - Avignon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Multiple Myeloma
Other Study ID Numbers
- OSTEOCAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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