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Vagus nerve stimulation

Stimulation of the vagus nerve as a potential cancer treatment.

Status
Terminated
Cancer types
Blood cancer
Trial phase
1

Funding

€37,585
ACF donation
€37,585
Actual trial cost

Why this trial

Low vagus nerve activity is associated with a worse cancer prognosis. The vagus nerve is one of the twelve cranial nerves that extends throughout the human body (larynx, trachea, oesophagus, heart, lungs, stomach and abdominal organs) and performs a variety of important functions, such as stimulating the digestive system. It is also the most important nerve of the parasympathetic nervous system and helps calm your body after a stress response by slowing your heart rate and lowering your blood pressure.

The scientific understanding of how cancerous tumours and metastases are formed and develop has changed, and today a greater emphasis is placed on the immediate environment of the tumour cells within the body and the presence of a number of processes that make the prognosis worse. These processes are excessive inflammatory responses, oxidative stress and sympathetic neurotransmitters. The activity of the vagus nerve can change or counter these three processes.

 

Why this intervention

Vagus nerve activity can be measured using the heart rate variability (HRV) that is recorded in an ECG (electrocardiogram). Various clinical studies have shown that a higher HRV is related to an improved prognosis (longer survival rates or lower tumour markers) for different types of cancer.

Vagus nerve stimulation could possibly bring a new treatment option to patients.

Trial design

The pilot study began by confirming published data regarding the role of the vagus nerve in cancer across patients with four different types of cancer. It also aimed to establish a connection between heart rate variability (HRV) and cancer prognosis. The study evaluated non-invasive techniques such as deep paced breathing (HRV-biofeedback) and non-invasive vagal nerve stimulation (VNS), with HRV-biofeedback showing the most promising results.

In the final phase, a pilot clinical study was conducted to assess whether HRV-biofeedback could decrease the levels of the tumor marker CEA (CarcinoEmbryonic Antigen) and enhance the quality of life in 35 patients diagnosed with stage 4 colon cancer.

 

Results

Based on retrospective studies in 4 cancer types (Non-Small cell lung cancer, Pancreatic cancer, Colorectal cancer, Ovarian cancer), a significant association between vagus nerve activity and prognosis in those cancer types was found and published in 3 scientific papers.

The pilot study in patients with advanced colon cancer did not recruit a sufficient number of patients and ended prematurely. Nevertheless, a trend was revealed, but it was not statistically significant, where CEA levels remained nearly unchanged in the controls, while a constant apparently declining pattern was shown in the HRV-biofeedback group. These preliminary results need to be confirmed in a large, randomised, controlled trial. A link to the publication can be found here.

Partners

Principal Investigator:

  • Prof. Dr. Yori Gidron, Faculty of Medicine & Pharmacy, Research Group Neuroscience, Vrije Universiteit Brussel, Brussels, Belgium

Sponsor:

  • Vrije Universiteit Brussel, Brussels, Belgium

Our role

Financial support

Why we support this trial

Intervention has little or no commercial value

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Expected survival benefit

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No major hurdle for clinical implementation

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Funding

€37,585
ACF donation
€37,585
Actual trial cost

Questions about this trial?

The Anticancer Fund
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References

De Couck, M., et al. (2013). The relationship between vagal nerve activity and clinical outcomes in prostate and non-small cell lung cancer patients. Oncology Reports, 30(5), 2435-41. doi:10.3892/or.2013.2725

Tracey, K. J. (2009). Reflex control of immunity. Nature Reviews Immunology, 9(6), 418–428. doi:10.1038/nri2566

Author: Kristine Beckers (Trial Manager)

Last updated: March 2024