Heart Rate Variability, Vagus Nerve and Cancer

May 10, 2024 updated by: Centre Hospitalier Henri Duffaut - Avignon

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Centre Hospitalier Henri Duffaut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Biological: CRP assessment
Blood CRP will be assessed during trial
Behavioral: QLQ-C30 questionnaire
Completion of QLQ-C30
Experimental: Osteopathic intervention
Patients will receive cancer treatment associated with osteopathic intervention
Biological: CRP assessment
Blood CRP will be assessed during trial
Behavioral: QLQ-C30 questionnaire
Completion of QLQ-C30
Other: Osteopathic intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Henri Duffaut - Avignon

Collaborators

Institut de Formation en Ostéopathie du Grand Avignon

Investigators

  • Principal Investigator: Borhane SLAMA, MD, Centre Hospitalier Henri Duffaut - Avignon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

September 19, 2021

Study Completion (Actual)

September 19, 2021

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSTEOCAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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