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Study on Propranolol for Reducing Anxiety in Patients with Pancreatic Cancer Before Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication propranolol on patients with pancreatic ductal adenocarcinoma, a type of pancreatic cancer. The trial aims to understand how propranolol, which is a medication commonly used to treat high blood pressure, affects anxiety levels before surgery and any changes in cancer-related genes. Participants in the study will be randomly assigned to receive either propranolol or a placebo, which is a tablet that looks like the medication but does not contain any active ingredients. The study will involve taking the assigned tablets twice daily for a short period before surgery.

The main purpose of this study is to evaluate how effective propranolol is in reducing anxiety before surgery and to observe any changes in the body's response to the cancer. Additionally, the study will monitor heart rate variability, which is a measure of how the heart responds to stress, to see if propranolol has any impact. This information will help researchers understand the potential benefits of using propranolol in this context and guide future studies.

Throughout the study, the safety and tolerance of propranolol will be closely monitored by checking for any side effects, such as changes in heart rate or blood pressure. The study will also assess how practical it is to use propranolol in this way, considering factors like how easy it is for participants to take the medication and any barriers to its use. The results from this trial will provide valuable insights for designing larger studies in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants are randomly assigned to one of two groups: one group receives propranolol, and the other receives a placebo. Each group consists of 15 participants.
Step 2
Medication administration
Participants take the assigned medication orally twice daily. The medication is administered until the day of surgery.
Step 3
Monitoring anxiety and heart rate variability
Anxiety levels are measured using the Hamilton Anxiety Rating Scale (HAM-A) and the Hospital Anxiety and Depression Scale (HADS).
Heart rate variability (HRV) is monitored using a Holter monitor, which records continuous ECG data.
Step 4
Safety assessment
Safety is evaluated by monitoring changes in resting heart rate (HR) and blood pressure (BP).
Participants are observed for any symptoms or side effects, such as light-headedness, lethargy, low blood pressure (hypotension), and slow heart rate (bradycardia).
Step 5
Surgery and follow-up
Participants undergo surgery for pancreatic cancer as planned.
Follow-up data is collected on postoperative complications and survival rates at 30 days, 90 days, and 1, 3, and 5 years after surgery.
Step 6
Feasibility assessment
The feasibility of the intervention is assessed using the APEASE framework, which evaluates factors such as affordability, practicability, effectiveness, acceptability, side effects, and equity.

Who can join the trial?

4 criteria

Patients must have a **suspected surgically resectable pancreatic cancer**. This means the cancer is believed to be removable by surgery.
There must be an **indication for surgical treatment with curative intent**. This means the surgery is planned with the goal of curing the cancer.
Patients must be at least **18 years old**.
Patients must be able to **provide written informed consent**. This means they understand the study and agree to participate by signing a document.

Who cannot join the trial?

10 criteria

Patients who are not diagnosed with Pancreatic ductal adenocarcinoma (PDAC), which is a type of pancreatic cancer.
Patients who are not undergoing abdominal surgery for suspected pancreatic cancer.
Patients who are not experiencing preoperative anxiety, which is anxiety felt before surgery.
Patients who are not able to take propranolol, a medication used to reduce anxiety and manage heart conditions.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they may have additional risks or need special protection.
Patients who are unable to comply with the study requirements, such as taking medication as instructed.
Patients who have medical conditions that could interfere with the study or make participation unsafe.
Patients who are pregnant or breastfeeding, as the effects of the study medication on pregnancy and breastfeeding are not known.
Patients who are participating in another clinical trial, as this could affect the results of the study.

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Verified sites

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Rigshospitalet
Copenhagen, Denmark
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Zealand University Hospital
Koege, Denmark

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Investigated drugs

Propranolol is a medication being tested in this trial for its effects on reducing anxiety before surgery in patients with suspected pancreatic cancer. It is a nonselective beta-adrenergic receptor blocker, which means it can help manage symptoms of anxiety by affecting the body's response to stress. The trial aims to see if propranolol can also influence certain gene expressions related to cancer growth. Additionally, the study will monitor how propranolol affects heart rate variability, which is an indicator of the body's autonomic nervous system function during surgery. The safety and tolerability of propranolol will also be assessed by observing any changes in heart rate and blood pressure during the treatment period.

What is already known about the treatment

Propranolol – Propranolol is administered orally in tablet form and is currently being studied in clinical trials for its effects on preoperative anxiety and tumorigenic changes in patients with pancreatic ductal adenocarcinoma. It is a well-established medication in medical literature, primarily used for managing high blood pressure, anxiety, and certain heart conditions. The main therapeutic indication in this trial is to reduce anxiety before surgery and potentially influence tumor-related gene expression. At the molecular level, propranolol works by blocking beta-adrenergic receptors, which are involved in the body's response to stress hormones like adrenaline. This action helps to decrease heart rate and blood pressure, providing a calming effect. Propranolol is classified as a non-selective beta-blocker, meaning it affects multiple types of beta receptors throughout the body.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – This is a type of cancer that originates in the ducts of the pancreas, which is an organ located behind the stomach. It is the most common form of pancreatic cancer and is known for its aggressive nature. The disease often progresses silently, with symptoms appearing only in advanced stages. These symptoms may include jaundice, weight loss, abdominal pain, and digestive issues. As the cancer grows, it can spread to nearby organs and tissues, complicating treatment. Early detection is challenging, making it crucial to understand its progression and impact on the body.