IMPULSExamining the Impact of Propranolol on Preoperative Anxiety and on Tumorigenic Changes in Patients With Pancreatic Ductal Adenocarcinomas: a Randomized, Triple-blinded, Placebo-controlled Pilot Trial
Propranolol
+ Placebo
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: March 20, 2024
Actual date on which the first participant was enrolled.This clinical trial aims to explore the effectiveness and safety of using propranolol, a medication, to reduce anxiety before surgery in patients suspected of having pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. The study includes 30 participants who will be randomly divided into two groups: one group will receive propranolol, while the other will receive a placebo. The trial seeks to determine if propranolol can help minimize anxiety and affect certain gene expressions associated with cancer, which could potentially improve surgical outcomes and overall treatment strategies for patients with PDAC. Participants in the study will take propranolol or a placebo twice daily. The study will measure anxiety levels using specific scales and monitor heart rate variability, which might indicate changes in the body's response to surgery. Blood samples and cancer tissue will be analyzed for changes in genes and proteins that may relate to cancer spread and inflammation. Follow-up assessments will occur 30 and 90 days after surgery, with long-term check-ins up to five years later. Safety is a key consideration, with close monitoring for any side effects like changes in heart rate or blood pressure. This study will help determine if propranolol is a feasible and effective option for managing preoperative anxiety and potentially affecting cancer progression.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients with suspected surgically resectable pancreatic cancer * Indication for surgical treatment with curative intend. * Provide written informed consent. * Patients minimum 18 years old. Women of childbearing potential (WOCBP) are defined as women ranging from the period of menarche till the post-menopausal period, unless permanently sterile (e.g., hysterectomy, bilateral salpingectomy and bilateral oophorectomy). Post-menopause is defined as no menses for 12 months without an alternative medical cause. WOCBP should use a secure and highly effective birth control (as stated in the "Recommendations related to contraception and pregnancy testing in clinical trials", version 1.1., section 4.1, from the Clinical Trials Facilitation and Coordination Group) during the entire period of the trial. In cases of uncertainty regarding pregnancy, additional pregnancy testing either as highly sensitive serum or urine pregnancy test can be used. Exclusion Criteria: * Patients with: * Chronic hypotension, systolic blood pressure \< 100 mg Hg for women and \< 110 mg Hg for men. * Bradycardia, pulse \< 50 beats per minute. * Asthma or chronic obstructive lung disease * Heart insufficiency with affected (\< 50 %) left ventricle ejection fraction (LVEF), treated or untreated. * Kidney insufficiency, defined as eGFR \< 20 ml/min. * Liver insufficiency defined as chronically high liver enzymes or known chronic liver disease (e.g., hepatitis, steatosis, cirrhosis). * Cor pulmonale * Cardiogenic shock * Severe peripheral circulatory disorders * Known or newly diagnosed current metabolic acidosis (e.g., in recent analysis of arterial puncture). * Known hypersensitivity to propranolol or to one or more of the excipients. * Currently untreated pheochromocytoma. * History of Prinzmetals angina. * History of sick sinus syndrome or atrioventricular block. * History of stroke or any previous cardiovascular event. * History of neoadjuvant oncological treatment for suspected primary pancreatic cancer. * Recent or present (within 3 months) use of propranolol or any other beta-blocker. * Recent or present (within 3 months) use of any of the following medications: anxiolytics, calcium channel blockers, beta-adrenergic receptor agonist. * Medical history that classifies the patient as frail or unsuitable for inclusion by the examining physician. * Histopathological examination revealing benign lesion. * Predictable poor compliance, due to pre-existing psychiatric disease, dementia or not able to read or speak sufficient Danish, resulting in not being able to provide a well-informed written consent.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Department of Surgical Gastroenterology
Copenhagen, DenmarkOpen Department of Surgical Gastroenterology in Google MapsIsmail Gögenur
Køge, Denmark