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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07700212
Enrollment
10
Registered
2026-07-13
Start date
2026-09-30
Completion date
2028-12-30
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Adenocarcinoma

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

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.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 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

MeasureTime frameDescription
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

CONTACTBrandon G. Smaglo, MD
bgsmaglo@mdanderson.org(713) 745-8763
PRINCIPAL_INVESTIGATORBrandon G. Smaglo, MD

UT MD Anderson

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026