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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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506553-37-00
Enrollment
30
Registered
2023-11-07
Start date
2024-04-23
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic ductal adenocarcinoma (PDAC)

Brief summary

Anxiety levels measured by The Hamilton Anxiety Rating Scale (HAM-A) and by The Hospital Anxiety and Depression Scale (HADS). The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QoL) for pancreatic cancer will be used to assess quality of life. HRV data calculated from continuous ECG gathered by a Holter monitor. Follow up data: postoperative complications, survival 30-, 90- days and 1, 3-, 5- years after surgery. Blood and tissue sampling

Detailed description

Safety: Changes in resting HR and BP during the intervention. Symptoms and side effects to medicine: light-headedness, lethargy, hypotension, bradycardia and other symptoms/side-effects. Tertiary end points: feasibility and implementation using the APEASE framework

Interventions

DRUGPLACEBO
DRUGPROPRANOLOL

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Anxiety levels measured by The Hamilton Anxiety Rating Scale (HAM-A) and by The Hospital Anxiety and Depression Scale (HADS). The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QoL) for pancreatic cancer will be used to assess quality of life. HRV data calculated from continuous ECG gathered by a Holter monitor. Follow up data: postoperative complications, survival 30-, 90- days and 1, 3-, 5- years after surgery. Blood and tissue sampling

Secondary

MeasureTime frame
Safety: Changes in resting HR and BP during the intervention. Symptoms and side effects to medicine: light-headedness, lethargy, hypotension, bradycardia and other symptoms/side-effects. Tertiary end points: feasibility and implementation using the APEASE framework

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026