Using Bethanechol with Chemotherapy for Pancreatic Cancer Treatment
Phase II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma
This study is testing if adding bethanechol to chemotherapy can help people with pancreatic cancer have better surgery outcomes and if it's safe to use.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05241249 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of bethanechol when combined with the chemotherapy drugs gemcitabine and nab-paclitaxel in patients with pancreatic adenocarcinoma. The primary goal is to assess whether this combination can improve R0 resection rates, which indicates successful surgical removal of the tumor. Additionally, the study will monitor the safety and tolerability of bethanechol and explore genomic biomarkers related to parasympathetic stimulation in pancreatic cancer. The hypothesis is that bethanechol may inhibit tumor growth by altering nerve conduction within tumors.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with pancreatic ductal adenocarcinoma who are planning to undergo neoadjuvant chemotherapy.
Not a fit: Patients with metastatic disease or significant comorbidities that contraindicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and reduce the likelihood of cancer recurrence in pancreatic cancer patients.
How similar studies have performed: While the use of bethanechol in this context is experimental, previous studies have shown promising results in animal models regarding its potential to inhibit cancer growth.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pancreatic Ductal Adenocarcinoma * Plan for neoadjuvant chemotherapy * Available diagnostic tissue adequate for biomarker analysis * Ability to tolerate PO meds and comply with study procedures Exclusion Criteria: * Metastatic disease * Evidence of GI obstruction * Baseline bradycardia (HR\<55) or hypotension (systolic blood pressure\<90) * Use of acetylcholinesterase inhibitors * Medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Susan E Bates, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.