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NCT03572283 · ClinicalTrials.gov registry record · Early Phase 1
Bethanechol Prior to Pancreatic Surgery
A Early Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
NCT03572283 is a Early Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 17 participants.
The verdict
NCT03572283, a Early Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the impact of bethanechol therapy on tumor activity by looking at biomarkers of proliferation, inflammation, and stem cell markers in post-treatment specimens compared to pre-treatment specimens and compared to other patients who were not treated with bethanechol prior to surgery. The investigators hypothesize that treatment with bethanechol will alter nerve conduction within tumors by stimulating the parasympathetic nervous system and reduce tumor proliferation, reduce macrophage activation, reduce tumor necrosis factor (TNF) alpha, and decrease human cluster of differentiation 44 (CD44) protein cancer stem cells. The safety objective is to assess the safety and tolerability of short course bethanechol prior to surgery and the impact of this treatment on immediate surgical outcomes. The investigators will assess all treatment-related toxicities with an emphasis on GI side effects and evaluate the impact of therapy on surgical delays or immediate post-op complications. All subjects will be contacted 1 week after beginning therapy to assess toxicity including GI specific toxicity and followed for safety for 30 days following completion of study medication. The investigators hypothesize that treatment for a minimum of 1 week will be tolerable in this selected patient population and will not interfere with progression to surgery or lead to increased surgical complications.
Interventions
- DRUG Bethanechol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-04-08 |
| Est. Completion | 2023-08-24 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03572283
The ClinicalTrials.gov registry entry for NCT03572283 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bethanechol is the first listed.
NCT03572283 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03572283 about?
NCT03572283 is a clinical study titled "Bethanechol Prior to Pancreatic Surgery". The primary objective of this study is to assess the impact of bethanechol therapy on tumor activity by looking at biomarkers of proliferation, inflammation, and stem cell markers in post-treatment specimens compared to pre-treatment specimens and compared to other patients who were not treated with...
What is the current status of trial NCT03572283?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2018-04-08. Estimated completion is 2023-08-24.
What interventions are being tested in trial NCT03572283?
The interventions under investigation include: Bethanechol (DRUG).
Who is sponsoring clinical trial NCT03572283?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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