The goal of this clinical research study is to learn about the safety and tolerability of the OnVagus device when used by patients who have metastatic pancreatic cancer and are receiving chemotherapy.
Primary Objective: To determine the safety and tolerability of the OnVagus device in patients wearing it while receiving chemotherapy. Secondary Objective: To determine the rate of cachexia arrest, as defined by weight stabilization or gain Exploratory Objectives: To analyze the changes in chemokine (C-C motif) ligand 2 (CCL2), tumor necrosis factor α (TNFa), acetylcholine (ACh), Growth/differentiation factor 15 (GDF15), Lipocalin-2 (LCN2), and liver function tests (LFTs) while patients receive vagal blockade. To determine the device's impact on progression-free survival (PFS) and overall survival (OS) between patients receiving vagal blockade.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The transcutaneous LFVB (tLFVB), involves placing a superficial, transcutaneous device over the right vagus nerve. The device can be self-applied, after participant/provider education on application is completed. While applied, the device provides the low frequency vagal blockade intended to arrest the cachexia process.
UT MD Anderson
Houston, Texas, United States
Safety and Adverse Events (AEs)
ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year.
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