A Phase 1 Trial Of Safety And Initial Efficacy Of Vagal Nerve Blockade For Cancer-Induced Cachexia In Patients With Metastatic Pancreatic Adenocarcinoma
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceTranscutaneous LFVB (tLFVB)
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.
Location
- UT MD AndersonHouston, Texas