Heart Rate Variability, Vagus Nerve and Cancer

NCT04718610 | Terminated

• 1 other identifier: OSTEOCAN
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cancer; Vagus nerve stimulation; Heart rate variability; Osteopathy

Outcome Measures

Primary Outcomes (1)

• 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

  up to 84 days

Secondary Outcomes (2)

• Serum concentration of C-Reactive Protein

  up to 84 days

• Time to definitive improvement in global health status / QoL

  up to 84 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients will receive only caner treatment. No osteopathic treatment.

Biological: CRP assessment; Behavioral: QLQ-C30 questionnaire

Osteopathic intervention

EXPERIMENTAL

Patients will receive cancer treatment associated with osteopathic intervention

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

Interventions

Osteopathic intervention OTHER

Nerve vagus stimulation

Osteopathic intervention

CRP assessment BIOLOGICAL

Blood CRP will be assessed during trial

Control; Osteopathic intervention

QLQ-C30 questionnaire BEHAVIORAL

Completion of QLQ-C30

Control; Osteopathic intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Henri Duffaut - Avignon: lead
• Institut de Formation en Ostéopathie du Grand Avignon: collaborator

Study Sites (1)

Centre Hospitalier Henri Duffaut

Avignon, 84000, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Colorectal Neoplasms; Multiple Myeloma; Lymphoma, Non-Hodgkin; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Study Officials

• Borhane SLAMA, MD

  Centre Hospitalier Henri Duffaut - Avignon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: January 12, 2021
• Primary Completion: September 19, 2021
• Study Completion: September 19, 2021
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)