A Phase 1 Trial Of Safety And Initial Efficacy Of Vagal Nerve Blockade For Cancer-Induced Cachexia In Patients With Metastatic Pancreatic Adenocarcinoma

Korábbi kezelés

• Implanted electrical device that passes through the neck (e.g.: cranial implant with battery pack in chest, and wires running through the neck).
• Metal implants in the neck, including the cervical spine.
• Prior severe cerebrovascular disease (e.g., intracranial aneurysm, intracranial hemorrhage, stroke).
• Prior severe cardiac disease, including but not limited to coronary artery disease (CAD), prior myocardial infarction (MI), uncontrolled congestive heart failure (CHF).

Más betegség

• History of cervical vagotomy on the right side of neck.

Egyéb

• Known structural abnormalities on the right side of neck, including but not limited to situs inversus, bulky R-neck lymphadenopathy, etc., that in the investigators' opinion would lead to inability to correctly place the device onto the vagus nerve.
• Recent (6 months or less) nerve block or botox injections to the head or neck.
• Pain specifically localized to the treatment area, the right side of the neck.

• 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).