M.D. Anderson Cancer Center
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 overal…
Inclusion Criteria: * Patients with metastatic pancreatic cancer. * Must have adenocarcinoma component (presence of combined histology is acceptable, as long as adenocarcinoma is present). * Weight loss from baseline of at least 5% (Baseline weight can be anytime from diagnosis onward). * Must have a tissue-based confirmation of diagnosis available. Tissue does not need to be a metastasis; primary tumor or prior surgery are acceptable sources. * Must have had progression of disease after one prior line of therapy in the metastatic setting. * Must be receiving or plan to receive another line o…
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.
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