Tests propranolol before surgery in people with pancreatic cancer
Tests propranolol, or a placebo, before surgery in adults with pancreatic cancer.
Plain-language title generated from the registry record
Registry title: Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.
Key facts
- Where
- Copenhagen and Køge, DenmarkSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are about to have surgery for pancreatic cancer that doctors think can be removed. Half take propranolol before surgery, half take a placebo.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Suspected pancreatic cancer that can be removed by surgery, with surgery planned to treat the cancer.
- Earlier treatment
- No treatment given before surgery for suspected pancreatic cancer. No propranolol or other beta-blocker in the last 3 months. No anxiety medicines, calcium channel blockers or beta-adrenergic receptor agonists in the last 3 months.
Main reasons for not taking part
- Low blood pressure, slow pulse (under 50 beats per minute), asthma or chronic obstructive lung disease
- Heart weakness (ejection fraction under 50 %), a past stroke or other heart or blood vessel event
- Kidney insufficiency (eGFR under 20 ml/min) or liver insufficiency or known chronic liver disease
- Allergy to propranolol or its ingredients
- Not able to give informed consent, for example because of dementia, psychiatric illness or not speaking enough Danish
Read by machine on 9 November 2026.
Where in Denmark
- Department of Surgical GastroenterologyCopenhagen, DenmarkTaking people
- Ismail GögenurKøge, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zealand University Hospital
- Trial code
- NCT06145074
- Record updated
- 28 March 2024
- Original description
The IMPULS trial is a randomized, triple-blinded, placebo controlled, single center, pilot trial examining the efficacy and safety of preoperative propranolol in patients scheduled for pancreatic cancer surgery. The study is conducted as a type 1 hybrid efficacy-implementation trial of 30 patients.Read full original descriptionShow less
Examining 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
The IMPULS trial is a randomized, triple-blinded, placebo controlled, single center, pilot trial examining the efficacy and safety of preoperative propranolol in patients scheduled for pancreatic cancer surgery. The study is conducted as a type 1 hybrid efficacy-implementation trial of 30 patients.
This study is designed to provide pilot data for a future larger perioperative study of propranolol with the aim of improving outcomes for pancreatic cancer surgery.
In total, 30 participants will be allocated in a 1:1 ratio with 15 participants enrolled in each trial arm (propranolol vs. placebo). Participants will be allocated to either 40 mg propranolol twice daily or placebo twice daily in 10 days prior to planned surgery.
Primary outcomes: Evaluating the efficacy of preoperative propranolol on anxiety and in pro-tumorigenic changes (e.g., in the tumor tissue and in blood samples) in patients undergoing surgery for pancreatic cancer. Furthermore, to obtain follow up data (e.g., 90-day mortality, postoperative complications etc. on the patients receiving propranolol versus placebo). Heart rate variability among the participants will also be examined.
Secondary: Examining the safety and tolerability of 40 mg preoperative propranolol twice daily in patients undergoing surgery for pancreatic cancer.
Tertiary: Evaluating the feasibility and implementation of the trial (using the APEASE framework). This will help identify barriers and enablers to a future larger study.
Short-time propranolol treatment is considered safe with a mild and manageable safety-profile. Risk-management, mitigations and guidelines to ensure patient safety is included in the protocol. Since this clinical trial is exploratory in nature, no sample-size calculation is performed.
Inclusion: 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: History of stroke or any previous cardiovascular event; Asthma or chronic obstructive lung disease; Liver insufficiency defined as chronically high liver enzymes or known chronic liver disease (e.g., hepatitis, steatosis, cirrhosis); Severe peripheral circulatory disorders; Known hypersensitivity to propranolol or to one or more of the excipients; History of Prinzmetals angina; History of sick sinus syndrome or atrioventricular block; History of neoadjuvant oncological treatment for suspected primary pancreatic cancer; 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; Heart insufficiency with affected (< 50 %) left ventricle ejection fraction (LVEF), treated or untreated; Kidney insufficiency, defined as eGFR < 20 ml/min; Recent or present (within 3 months) use of any of the following medications: anxiolytics, calcium channel blockers, beta-adrenergic receptor agonist; Patients with:; Chronic hypotension, systolic blood pressure < 100 mg Hg for women and < 110 mg Hg for men; Bradycardia, pulse < 50 beats per minute; Cor pulmonale; Cardiogenic shock; Known or newly diagnosed current metabolic acidosis (e.g., in recent analysis of arterial puncture); Currently untreated pheochromocytoma; Recent or present (within 3 months) use of propranolol or any other beta-blocker; Medical history that classifies the patient as frail or unsuitable for inclusion by the examining physician; Histopathological examination revealing benign lesion.