Metastatic Pancreatic Adenocarcinoma
Conditions
Brief 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.
Detailed 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 overall survival (OS) between patients receiving vagal blockade.
Interventions
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.
Sponsors
Study design
Eligibility
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 of therapy in the metastatic setting. o If therapy is being administered outside MD Anderson, the patient is still eligible for this trial. o Enrollment onto a therapeutic clinical trial as this second line therapy is not explicitly excluded. * Must have triple ECG results available. Patients will be ineligible if they present: o Second- or third-degree block. * Prolonged QT wave. * Atrial fibrillation or flutter. * Uncontrolled ventricular fibrillation or flutter. * Premature ventricular contractions (PVC).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year. | ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
UT MD Anderson