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Cholinergic Agonist
Bethanechol for Pancreatic Cancer
Phase < 1
Recruiting
Led By Susan E Bates, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 28 days after surgery
Awards & highlights
Study Summary
This trial is testing whether the drug bethanechol has an effect on tumor activity, by looking at biomarkers of the tumor before and after treatment. The goal is to see if bethanechol therapy alters nerve conduction within tumors, which could reduce tumor proliferation.
Who is the study for?
This trial is for adults over 18 with resectable pancreatic cancer, who can consent to the study and have a life expectancy of more than 3 months. They should be relatively active (ECOG Performance Status of 0 or 1) and not pregnant. Exclusions include recent urinary bladder surgery, unstable health conditions, psychiatric disorders that affect participation, pregnancy/breastfeeding plans within the next four months post-trial, allergies to bethanechol, certain uncontrolled medical conditions like hyperthyroidism or low blood pressure, prior treatments for current cancer episode, use of specific drugs like acetylcholinesterase inhibitors or beta-blockers.Check my eligibility
What is being tested?
The trial tests if taking bethanechol before pancreatic surgery can change tumor activity by affecting nerve signals in tumors. It looks at changes in biomarkers related to cell growth and inflammation in treated patients versus untreated ones. The safety aspect focuses on how well patients tolerate bethanechol and its effects on surgical outcomes.See study design
What are the potential side effects?
Potential side effects include gastrointestinal issues such as upset stomach or cramps since bethanechol acts on the digestive system. Other concerns are possible delays in surgery due to these side effects or complications immediately after operation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 28 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 28 days after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cell proliferation by Ki-67 expression in tumor cells
Secondary outcome measures
Number of Adverse Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: BethanecholExperimental Treatment1 Intervention
Patients with pancreatic adenocarcinoma will receive bethanechol prior to pancreatic surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bethanechol
2009
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,815 Total Patients Enrolled
Susan E Bates, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for more than 3 months.Experience sudden changes in blood vessel functionYou have been diagnosed with Parkinson's disease in the past.You have asthma.You are allergic to bethanechol.You have a thyroid condition that is not controlled by medication.You have a peptic ulcer that is not getting better with oral medication.You have already had chemotherapy or radiation treatment for your current pancreatic cancer.You are currently taking a medication called acetylcholinesterase inhibitor or beta-blocker.Your resting heart rate is less than 50 beats per minute.You have been diagnosed with resectable pancreatic ductal adenocarcinoma, or you are willing to have a biopsy to confirm the diagnosis before starting treatment.Your blood pressure is consistently very low when you are resting.You have symptoms of chest pain or leg pain due to blocked arteries in the heart or legs.You have had seizures or needed medication to prevent seizures in the past 5 years.You have had surgery to remove and reconnect part of your digestive system within the past 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: Bethanechol
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are involved in the current experiment?
"Affirmative. Clinicaltrials.gov's records indicate that this clinical trial is presently in search of participants, having been published on April 8th 2018 and last amended on November 29th 2022. The study needs to recruit 18 people from a single medical centre."
Answered by AI
Does the trial currently accept new patients?
"Affirmative. Clinicaltrials.gov lists this trial as presently recruiting and reveals that it was first posted on April 8th 2018 and last updated November 29th 2022. 18 patients are expected to be enrolled at a single study centre."
Answered by AI
Have any other researchers conducted investigations into Bethanechol?
"Presently, only 1 clinical trial is being conducted related to Bethanechol, which does not involve Phase 3. The majority of the research for this treatment originates from New york; however, other locations are also running studies in order to further investigate its effects."
Answered by AI
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