Recruiting

Study of Digitoxin with Chemotherapy for Patients with Inoperable Pancreatic Cancer

Verified siteRegistered drugNo placebo

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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 a medication called Digitoxin in combination with chemotherapy for patients with pancreatic cancer that cannot be removed by surgery. The main goal of the study is to improve the survival of these patients. Pancreatic cancer is a serious disease where cancer cells form in the tissues of the pancreas, an organ that helps with digestion and blood sugar regulation.

Participants in the study will take Digitoxin tablets by mouth. The study will last for up to one year, during which time the participants' health and response to the treatment will be closely monitored. The study will look at how long patients live without the cancer getting worse, as well as their overall survival. Researchers will also assess the safety of the treatment and any side effects that may occur.

Throughout the study, various health assessments will be conducted, including checking blood markers that can indicate the presence of cancer. The quality of life of participants will also be evaluated using specific questionnaires. Additionally, the study will involve analyzing certain proteins in the blood that are important for cancer and inflammation. This research aims to provide valuable insights into the potential benefits of using Digitoxin alongside chemotherapy for treating pancreatic cancer.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, you will be required to provide written consent to participate. This confirms your understanding and agreement to be part of the trial.
You will undergo a series of initial assessments to confirm eligibility, including a review of your medical history and a physical examination.
Step 2
Initial testing
A pregnancy test will be conducted for female patients of childbearing potential within 72 hours before starting treatment. This ensures safety and eligibility for the trial.
Baseline measurements of serum tumor markers, such as CA19-9, CEA, and CA125, will be taken. These markers help in monitoring the disease.
Step 3
Start of treatment
You will begin taking digitoxin tablets orally. The dosage is 0.07 mg per tablet. The frequency and duration of administration will be specified by the study team.
The primary goal of this treatment is to improve survival in patients with inoperable pancreatic cancer.
Step 4
Ongoing assessments
Every three months, your serum tumor markers will be evaluated to monitor the biochemical response to the treatment.
Radiographic assessments will be conducted to evaluate disease progression. This involves imaging tests to check the size and spread of the cancer.
Step 5
Quality of life evaluations
Your quality of life will be assessed using specific questionnaires, EORTC QLQ-C30 and EORTC QLQ-PAN-26, designed to understand the impact of the treatment on your daily life.
Step 6
Safety monitoring
Throughout the trial, any side effects or adverse events will be closely monitored to ensure the safety and tolerability of the treatment.
Regular laboratory tests will be conducted to check for any changes in your health status.
Step 7
Translational studies
Cytokines, which are proteins important for cancer and inflammation, will be analyzed before starting digitoxin and at three months of treatment. This helps in understanding the biological effects of the treatment.
Step 8
Completion of trial
The trial is expected to continue until October 2027. Your participation will contribute to understanding the effectiveness and safety of digitoxin in combination with chemotherapy for pancreatic cancer.

Who can join the trial?

10 criteria

Must be a male or female who is 18 years or older.
Male patients with a female partner who can have children must agree to use a reliable method of birth control, such as a condom, during the study and for 6 months after the last dose of the study medication. Choosing not to have sex is acceptable if it is the usual lifestyle choice.
Must have a WHO performance status of 0-2, which means the patient is fully active or able to carry out light work.
Must have a confirmed diagnosis of inoperable adenocarcinoma of the pancreas, which means the cancer cannot be removed by surgery. This must be confirmed by examining tissue from the pancreas or a spread of the cancer.
Must be newly diagnosed and not have started any other treatment for pancreatic cancer.
Must have a disease that can be measured or evaluated by scans, according to specific guidelines (RECIST v1.1).
Must be able to take care of their own medication.
Must have given written consent to participate in the trial.
Female patients who can have children must have a negative pregnancy test within 72 hours before receiving the first treatment. If the urine test is positive or unclear, a blood test will be required.
Female patients who can have children must agree to use a reliable method of birth control during the study and for 6 months after the last dose of the study medication. Choosing not to have sex is acceptable if it is the usual lifestyle choice.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer besides pancreatic cancer cannot participate.
Patients who have had surgery to remove their pancreatic cancer are not eligible.
Patients who are under the age of 18 or over the age of 75 cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients who have a serious infection or illness that affects their immune system cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients who have a history of severe allergic reactions to medications used in the trial cannot participate.
Patients who have a mental health condition that affects their ability to understand the trial or follow instructions are not eligible.

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Verified
Skaraborg Hospital-Vaestra Goetalandsregionen
Skovde, Sweden

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Investigated drugs

Digitoxin
is a medication that is being studied for its potential to help treat pancreatic cancer. It is traditionally used to treat heart conditions, but researchers are exploring its ability to work alongside chemotherapy to improve the survival of patients with inoperable pancreatic cancer. In this trial, digitoxin is being combined with chemotherapy to see if it can enhance the effectiveness of the cancer treatment.
Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. It works by stopping or slowing the growth of cancer cells, which grow and divide quickly. In this trial, chemotherapy is being used in combination with digitoxin to see if the two treatments together can improve outcomes for patients with inoperable pancreatic cancer. The goal is to find a more effective treatment approach that can help patients live longer.

Digitoxin

What is already known about the treatment

Digitoxin – Digitoxin is administered orally in the form of a tablet. It is currently being studied in combination with chemotherapy for treating inoperable pancreatic cancer, as part of a clinical trial aimed at improving patient survival. The main therapeutic indication for digitoxin in this context is pancreatic cancer. At the molecular level, digitoxin works by inhibiting a specific enzyme in the heart and other tissues, which can affect cell growth and survival. It is classified pharmacologically as a cardiac glycoside, traditionally used for heart conditions, but now being explored for its potential in cancer therapy.

Investigated diseases

Pancreatic adenocarcinoma – Pancreatic adenocarcinoma is a type of cancer that originates in the tissues of the pancreas, an organ located behind the stomach. It typically begins in the ducts that carry digestive enzymes out of the pancreas. As the disease progresses, it can invade nearby organs and spread to other parts of the body. The cancer cells grow uncontrollably, forming a mass or tumor that can interfere with the normal functions of the pancreas. Over time, this can lead to symptoms such as jaundice, weight loss, and abdominal pain. The progression of the disease can vary, but it often advances quickly due to its aggressive nature.