Using propranolol before surgery for pancreatic cancer
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
This study is testing whether taking propranolol before surgery can help reduce anxiety and improve outcomes for people with suspected pancreatic cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT06145074 on ClinicalTrials.gov |
What this trial studies
This pilot trial examines the safety and efficacy of propranolol, a beta-blocker, in patients scheduled for surgery due to suspected pancreatic ductal adenocarcinoma (PDAC). A total of 30 participants will be randomly assigned to receive either propranolol or a placebo for 10 days prior to surgery. The study aims to evaluate the impact of propranolol on preoperative anxiety and tumor-related changes, with the goal of providing data for future larger trials. The trial is designed as a triple-blinded, placebo-controlled study to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with suspected surgically resectable pancreatic cancer who are eligible for curative surgical treatment.
Not a fit: Patients with non-resectable pancreatic cancer or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce anxiety for patients undergoing surgery for pancreatic cancer.
How similar studies have performed: While this specific approach is novel, similar studies exploring the effects of beta-blockers on surgical outcomes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen and 1 other locations
- Department of Surgical Gastroenterology — Copenhagen, Denmark (Recruiting)
- Ismail Gögenur — Køge, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Ismail Gögenur, Professor — Center for Surgical Science, Zealand University Hospital
- Study coordinator: Ismail Gögenur, Professor
- Email: igo@regionsjaelland.dk
- Phone: +4547323181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.