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

Official record

Identifier

NCT07700212

Recruiting locations

country

United States

Interventions studied

Transcutaneous LFVB (tLFVB)

Lead sponsor

M.D. Anderson Cancer Center

Target enrolment

10 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Not yet recruiting

First posted

Jul 13, 2026

Last updated on the registry

Aug 14, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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).

Exclusion Criteria:

Exclusion Criteria

* History of cervical vagotomy on the right side of neck.
* 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.
* 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.
* 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.
* 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).

Indexed under

Pancreatic Cancer