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Tests treatment safety and results for Pancreatic Cancer
Official title Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.
ClinicalTrials.gov ID: NCT06145074
What this study is testing
What is Propranolol?
Propranolol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pancreatic cancer.
Also referred to as Inderal, Propal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Køge, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Køge, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.