Heart Rate Variability, Vagus Nerve and Cancer

Centre Hospitalier Henri Duffaut - Avignon

Status: Terminated

Conditions: Multiple Myeloma; Lung Cancer; Non Hodgkin Lymphoma; Colorectal Cancer

Treatments: Behavioral: QLQ-C30 questionnaire; Other: Osteopathic intervention; Biological: CRP assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04718610

OSTEOCAN

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Control

Active Comparator group

Description:

Patients will receive only caner treatment. No osteopathic treatment.

Treatment:

Behavioral: QLQ-C30 questionnaire

Biological: CRP assessment

Osteopathic intervention

Experimental group

Description:

Patients will receive cancer treatment associated with osteopathic intervention

Treatment:

Behavioral: QLQ-C30 questionnaire

Other: Osteopathic intervention

Biological: CRP assessment