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

NCT07700212 | Not Yet Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: 2025-1708NCI-2026-05254
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Treatment with OnVagus device

EXPERIMENTAL

Device will be applied by participant/caregiver daily for 30 min/day for 4 weeks; if well tolerated, 30 min twice per day for the following 4 weeks.

Device: Transcutaneous LFVB (tLFVB)

Interventions

Transcutaneous LFVB (tLFVB) DEVICE

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.

Treatment with OnVagus device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

Study Officials

• Brandon G. Smaglo, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon G. Smaglo, MD

CONTACT

(713) 745-8763; bgsmaglo@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

US (1)