Heart Rate Variability, Vagus Nerve and Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04718610
• Other study ID #: OSTEOCAN
• Status: Terminated
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: September 19, 2021

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Henri Duffaut - Avignon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: September 19, 2021
• Est. primary completion date: September 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Lung Cancer
• Multiple Myeloma
• Non Hodgkin Lymphoma

Intervention

Other:
• Osteopathic intervention
Nerve vagus stimulation

Biological:
• CRP assessment
Blood CRP will be assessed during trial

Behavioral:
• QLQ-C30 questionnaire
Completion of QLQ-C30

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Duffaut	Avignon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Duffaut - Avignon	Institut de Formation en Ostéopathie du Grand Avignon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum concentration of C-Reactive Protein	To assess the effect of vagus nerve osteopathic stimulations on systemic inflammatory	up to 84 days
Secondary	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