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)
- Conditions
- Pancreatic ductal adenocarcinoma (PDAC)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506553-37-00
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Patients with suspected surgically resectable pancreatic cancer. Indication for surgical treatment with curative intend. Patients minimum 18 years old. Patients who can provide written informed consent.
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). Currently untreated pheochromocytoma. History of Prinzmetals angina. History of sick sinus syndrome or atrioventricular block. History of neoadjuvant oncological treatment for suspected primary pancreatic cancer. Recent or present (within 1 months) use of propranolol or any other beta-blocker. Recent or present (within 1 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method