Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.
Status:
Recruiting
Trial end date:
2035-12-31
Target enrollment:
Participant gender:
Summary
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.