A Phase 1 Trial Of Safety And Initial Efficacy Of Vagal Nerve Blockade For Cancer-Induced Cachexi… (NCT07700212) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1 Trial Of Safety And Initial Efficacy Of Vagal Nerve Blockade For Cancer-Induced Cachexia In Patients With Metastatic Pancreatic Adenocarcinoma
United States10 participantsStarted 2026-09-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year.