Metastatic Pancreatic AdenocarcinomaPhase 1NCT07700212
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 study testing Transcutaneous LFVB (tLFVB) in people with Metastatic Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Transcutaneous LFVB (tLFVB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Brandon G. Smaglo, MD, 713-745-8763, bgsmaglo@mdanderson.org
Brandon G. Smaglo, MD
About this study
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.
Read the 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.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Transcutaneous LFVB (tLFVB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous LFVB (tLFVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brandon G. Smaglo, MD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700212
- Sponsor's protocol ID
- 2025-1708
- Other IDs
- NCI-2026-05254
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial Of Safety And Initial Efficacy Of Vagal Nerve Blockade For Cancer-Induced Cachexia In Patients With Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07700212
- Acronym / sponsor ID
- 2025-1708
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with OnVagus device | Experimental | Device: Transcutaneous LFVB (tLFVB)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment with OnVagus device |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- UT MD Anderson WebsiteLink provided by the sponsor.
Related trials for Metastatic Pancreatic Adenocarcinoma
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon G. Smaglo, MD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcutaneous LFVB (tLFVB) in people with Metastatic Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon G. Smaglo, MD ((713) 745-8763, bgsmaglo@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.