Heart Rate Variability, Vagus Nerve and Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2021-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer Colorectal Cancer Multiple Myeloma Non Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

For each cancer type, 30 patients will be included. These patients will be randomized into two groups.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Patients will receive only caner treatment. No osteopathic treatment.

Group Type ACTIVE_COMPARATOR

CRP assessment

Intervention Type BIOLOGICAL

Blood CRP will be assessed during trial

QLQ-C30 questionnaire

Intervention Type BEHAVIORAL

Completion of QLQ-C30

Osteopathic intervention

Patients will receive cancer treatment associated with osteopathic intervention

Group Type EXPERIMENTAL

Osteopathic intervention

Intervention Type OTHER

Nerve vagus stimulation

CRP assessment

Intervention Type BIOLOGICAL

Blood CRP will be assessed during trial

QLQ-C30 questionnaire

Intervention Type BEHAVIORAL

Completion of QLQ-C30

Interventions

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Osteopathic intervention

Nerve vagus stimulation

Intervention Type OTHER

CRP assessment

Blood CRP will be assessed during trial

Intervention Type BIOLOGICAL

QLQ-C30 questionnaire

Completion of QLQ-C30

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No