Heart Rate Variability, Vagus Nerve and Cancer

Not Applicable

Terminated

• Conditions: Non Hodgkin Lymphoma; Multiple Myeloma; Lung Cancer; Colorectal Cancer
• Interventions: Biological: CRP assessment; Other: Osteopathic intervention; Behavioral: QLQ-C30 questionnaire

• Registration Number: NCT04718610
• Lead Sponsor: Centre Hospitalier Henri Duffaut - Avignon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Primary Completion: 2021-09-19
• Study Completion: 2021-09-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	QLQ-C30 questionnaire	Patients will receive only caner treatment. No osteopathic treatment.
Control	CRP assessment	Patients will receive only caner treatment. No osteopathic treatment.
Osteopathic intervention	Osteopathic intervention	Patients will receive cancer treatment associated with osteopathic intervention
Osteopathic intervention	QLQ-C30 questionnaire	Patients will receive cancer treatment associated with osteopathic intervention
Osteopathic intervention	CRP assessment	Patients will receive cancer treatment associated with osteopathic intervention

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Henri Duffaut; 🇫🇷 Avignon, France