Using propranolol before surgery for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.