Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma

  • End date
    Sep 22, 2024
  • participants needed
  • sponsor
    Susan E. Bates
Updated on 22 March 2022
pancreatic adenocarcinoma
cancer chemotherapy
pancreatic ductal adenocarcinoma
breast ductal carcinoma


The primary objective of this study is to assess the impact of bethanechol therapy on R0 resection rates. The safety objective will be assessment of the safety and tolerability of bethanechol in combination with gemcitabine and nab-paclitaxel. The exploratory objective will be to evaluate genomic biomarkers associated with parasympathetic stimulation in pancreatic cancer, and the ability to reduce tumor growth rate.


The purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that the medication is easy to tolerate and that it shows signs of slowing cancer cell growth. The investigators hypothesize that treatment with bethanechol will alter nerve conduction within tumors by stimulating the parasympathetic nervous system and reduce tumor proliferation, decrease CD44+ expression in cancer cells, decrease tumor growth rate resulting in an improved R0 resection rate.

Condition Pancreas Cancer
Treatment Gemcitabine, Nab-paclitaxel, Bethanechol
Clinical Study IdentifierNCT05241249
SponsorSusan E. Bates
Last Modified on22 March 2022


Yes No Not Sure

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
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