Recruiting

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

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What is being tested

Propranolol

+ Placebo

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorZealand University Hospital
Study ContactIsmail Gögenur, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleExamining 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
NCT06145074
Principal SponsorZealand University Hospital
Study ContactIsmail Gögenur, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Propranolol will be administered 40 mg twice daily (morning and evening) in 10 days prior to surgery for pancreatic cancer

Group II

Placebo
Placebo will be administered twice daily (morning and evening) in 10 days prior to surgery for pancreatic cancer.

Study 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

Recruiting

Department of Surgical Gastroenterology

Copenhagen, DenmarkOpen Department of Surgical Gastroenterology in Google Maps
Recruiting soon

Ismail Gögenur

Køge, Denmark
Recruiting
2 Study Centers