Clinical trial NCT04718610: Heart Rate Variability, Vagus Nerve and Cancer
Official title: Effects of Vagus Nerve Osteopathic Stimulations on Heart Rate Variability of Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Colorectal Cancer
Multiple Myeloma
Non Hodgkin Lymphoma
Keywords: Cancer
Vagus nerve stimulation
Heart rate variability
Osteopathy
Lead sponsor: Centre Hospitalier Henri Duffaut - Avignon
Sponsor class: OTHER
Collaborators: name: Institut de Formation en Ostéopathie du Grand Avignon
First posted: 2021-01-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For each cancer type, 30 patients will be included. These patients will be randomized into two groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Heart Rate Variability measured by SDNN (Standard Deviation of all NN intervals) from baseline to the end of osteopathic treatment
timeFrame: up to 84 days
Secondary outcomes:
measure: Serum concentration of C-Reactive Protein
timeFrame: up to 84 days
measure: Time to definitive improvement in global health status / QoL
timeFrame: up to 84 days
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
Study officials:
affiliation: Centre Hospitalier Henri Duffaut - Avignon
name: Borhane SLAMA, MD
role: PRINCIPAL_INVESTIGATOR
References: