Heart Rate Variability, Vagus Nerve and Cancer
Primary Purpose
Lung Cancer, Colorectal Cancer, Multiple Myeloma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathic intervention
CRP assessment
QLQ-C30 questionnaire
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring Cancer, Vagus nerve stimulation, Heart rate variability, Osteopathy
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
Sites / Locations
- Centre Hospitalier Henri DuffautRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Osteopathic intervention
Arm Description
Patients will receive only caner treatment. No osteopathic treatment.
Patients will receive cancer treatment associated with osteopathic intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Serum concentration of C-Reactive Protein
To assess the effect of vagus nerve osteopathic stimulations on systemic inflammatory
Time to definitive improvement in global health status / QoL
To assess the effect of vagus nerve osteopathic stimulations on health related quality of life
Full Information
NCT ID
NCT04718610
First Posted
January 14, 2021
Last Updated
January 18, 2021
Sponsor
Centre Hospitalier Henri Duffaut - Avignon
Collaborators
Institut de Formation en Ostéopathie du Grand Avignon
1. Study Identification
Unique Protocol Identification Number
NCT04718610
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
January 12, 2023 (Anticipated)
Study Completion Date
January 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Duffaut - Avignon
Collaborators
Institut de Formation en Ostéopathie du Grand Avignon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Colorectal Cancer, Multiple Myeloma, Non Hodgkin Lymphoma
Keywords
Cancer, Vagus nerve stimulation, Heart rate variability, Osteopathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For each cancer type, 30 patients will be included. These patients will be randomized into two groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients will receive only caner treatment. No osteopathic treatment.
Arm Title
Osteopathic intervention
Arm Type
Experimental
Arm Description
Patients will receive cancer treatment associated with osteopathic intervention
Intervention Type
Other
Intervention Name(s)
Osteopathic intervention
Intervention Description
Nerve vagus stimulation
Intervention Type
Biological
Intervention Name(s)
CRP assessment
Intervention Description
Blood CRP will be assessed during trial
Intervention Type
Behavioral
Intervention Name(s)
QLQ-C30 questionnaire
Intervention Description
Completion of QLQ-C30
Primary Outcome Measure Information:
Title
Change of Heart Rate Variability measured by SDNN (Standard Deviation of all NN intervals) from baseline to the end of osteopathic treatment
Description
To assess the effect of vagus nerve osteopathic stimulations on Heart Rate Variability
Time Frame
up to 84 days
Secondary Outcome Measure Information:
Title
Serum concentration of C-Reactive Protein
Description
To assess the effect of vagus nerve osteopathic stimulations on systemic inflammatory
Time Frame
up to 84 days
Title
Time to definitive improvement in global health status / QoL
Description
To assess the effect of vagus nerve osteopathic stimulations on health related quality of life
Time Frame
up to 84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierrick MARTINEZ, OsteopatheDO
Phone
+33432759392
Email
pierrick.martinez10@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyne GRINAND, PhD
Phone
+33432759392
Email
grinand.marilyne@ch-avignon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borhane SLAMA, MD
Organizational Affiliation
Centre Hospitalier Henri Duffaut - Avignon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Henri Duffaut
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Borhane SLAMA, MD
Phone
+33432759392
Email
bslama@ch-avignon.fr
First Name & Middle Initial & Last Name & Degree
Marilyne GRINAND, PhD
Phone
+33432759392
Email
grinand.marilyne@ch-avignon.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Heart Rate Variability, Vagus Nerve and Cancer
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