A Phase 1 Trial Of Safety And Initial Efficacy Of Vagal Nerve Blockade For Cancer-Induced Cachexia In Patients With Metastatic Pancreatic Adenocarcinoma
NCT07700212 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-08-14
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
Interventions
- DEVICE
-
Transcutaneous 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 & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Brandon G. Smaglo, MD · UT MD Anderson
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2026-12-30
- Completion
- 2028-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
NCT04054362 ·Status: COMPLETED ·Phase: PHASE2
-
Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)
NCT07282834 ·Status: RECRUITING ·Phase: PHASE2
-
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)
NCT03652428 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
NCT00047710 ·Status: COMPLETED ·Phase: PHASE1
-
Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer
NCT04940286 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer
NCT00222469 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
NCT02004262 ·Status: COMPLETED ·Phase: PHASE2
-
PDAC-PATHWAYS: A Digital Informational and Supportive Care App for Patients Initiating Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma
NCT07047807 ·Status: RECRUITING ·Phase: NA
-
Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients
NCT02400398 ·Status: COMPLETED
-
Phase I Trial of LCL161 and Gemcitabine Plus Nab-Paclitaxel in Metastatic Pancreatic Cancer
NCT01934634 ·Status: UNKNOWN ·Phase: PHASE1
-
Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer
NCT02283372 ·Status: COMPLETED ·Phase: PHASE1
-
Study of 5-fluorouracil (5-FU), Nab®1-paclitaxel, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Cancer
NCT02620800 ·Status: COMPLETED ·Phase: PHASE1
-
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery
NCT00727441 ·Status: COMPLETED ·Phase: PHASE2
-
Cvac as Maintenance Treatment Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
NCT02310971 ·Status: WITHDRAWN ·Phase: PHASE2
-
Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery
NCT04025840 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
NCT04665947 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel.
NCT03076216 ·Status: COMPLETED ·Phase: NA
-
Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma
NCT00177242 ·Status: COMPLETED ·Phase: PHASE2
-
A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade for Advanced Biliopancreatic Cancer With Pain
NCT07326137 ·Status: RECRUITING
-
Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients With Locally Advanced Pancreatic Cancer
NCT02394535 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
NCT04014478 ·Status: UNKNOWN ·Phase: NA
-
EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
NCT00028782 ·Status: TERMINATED ·Phase: NA
-
Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma
NCT07377045 ·Status: RECRUITING ·Phase: PHASE1
-
ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
NCT06904378 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer
NCT07701486 ·Status: RECRUITING ·Phase: PHASE1/PHASE2