RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma

Quick Facts

Study Start:2022-02-01
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05241249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pancreatic Ductal Adenocarcinoma
  2. * Plan for neoadjuvant chemotherapy
  3. * Available diagnostic tissue adequate for biomarker analysis
  4. * Ability to tolerate PO meds and comply with study procedures
  1. * Metastatic disease
  2. * Evidence of GI obstruction
  3. * Baseline bradycardia (HR\<55) or hypotension (systolic blood pressure\<90)
  4. * Use of acetylcholinesterase inhibitors
  5. * Medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.

Contacts and Locations

Study Contact

Research Nurse Navigator
CONTACT
212-342-5162
cancerclinicaltrials@cumc.columbia.edu
Susan E Bates, MD
CONTACT
seb2227@cumc.columbia.edu

Principal Investigator

Susan E Bates, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Susan E. Bates

  • Susan E Bates, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2025-01

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Pancreas
  • pancreatic adenocarcinoma
  • adenocarcinoma
  • bethanechol
  • parasympathetic

Additional Relevant MeSH Terms

  • Pancreas Cancer