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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07700212
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with OnVagus device
    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.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Brandon G. Smaglo, MD
[email protected]
713-745-8763
Brandon G. Smaglo, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UT MD Anderson· Houston, TX

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