Vagal Nerve Blockade for Pancreatic Cancer

This trial explores a new device called OnVagus, which might assist individuals with metastatic pancreatic cancer who are also undergoing chemotherapy. The research aims to assess the safety and comfort of this device, applied to the neck to potentially block nerve signals related to cancer growth. This process is known as Transcutaneous Low-Frequency Vagal Nerve Blockade (tLFVB). Participants will use the device daily for several weeks. The trial seeks individuals with pancreatic cancer that has spread, especially those who have lost weight since diagnosis and have already undergone one round of treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative device.

Research has shown that treatments involving the vagus nerve, such as the OnVagus device, are generally safe and well-tolerated. In a study with breast cancer patients, a similar method using vagus nerve stimulation proved safe, with very few side effects reported. Another study supported the safety of vagus nerve treatments for managing rheumatoid arthritis. Although specific data for the OnVagus device in pancreatic cancer is not yet available, similar devices used in other conditions suggest it could be safe. As this trial is in its early stages, the primary goal is to further explore its safety.¹²³⁴⁵

Unlike traditional treatments for pancreatic cancer, which often involve chemotherapy, radiation, or surgery, transcutaneous Low-Frequency Vagal Nerve Blockade (tLFVB) with the OnVagus device is unique because it leverages a non-invasive method to potentially improve patient outcomes. This treatment involves applying a device externally to stimulate the vagal nerve, which may help modulate pain and inflammation associated with the condition. Researchers are excited about this approach because it offers a novel mechanism of action by targeting the nervous system, potentially reducing side effects compared to standard systemic therapies. Additionally, it's designed for daily home use, making it more convenient for patients.

Research has shown that blocking certain nerve signals, such as those targeted by the OnVagus device, might help slow the growth of pancreatic cancer. Participants in this trial will use the OnVagus device, designed to block these nerve signals. One study found that combining this nerve-blocking method with chemotherapy significantly shrank tumors. Other studies suggest a link between high vagal nerve activity and better cancer outcomes. Additionally, evidence indicates that stimulating the vagal nerve to reduce inflammation can enhance the effectiveness of cancer treatments. While these findings are promising, they remain in the early stages of research.¹²³⁴⁵