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Study on Tranexamic Acid to Reduce Early Relapse in Melanoma Patients Undergoing 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 a medication called Tranexamic Acid on patients with melanoma, a type of skin cancer. The study aims to determine if using Tranexamic Acid during surgery can reduce the chances of the cancer returning soon after treatment. The trial involves patients who are undergoing a specific type of surgery known as a sentinel lymph node biopsy, which helps in assessing the spread of melanoma.

Participants in the study will receive either Tranexamic Acid or a placebo, which is a substance with no active medication. Tranexamic Acid is administered in two forms: as an injection called Pilexam and as a tablet known as Cyklonova. The study will compare the outcomes of those receiving the actual medication with those receiving the placebo to see if there is a significant difference in the rate of cancer relapse.

The trial will monitor participants over a period to observe any relapses of melanoma, as well as any side effects or complications that may arise after surgery. The goal is to see if Tranexamic Acid can effectively reduce the risk of melanoma returning and improve the overall outcomes for patients undergoing surgery for this condition. The study is expected to continue until 2028, providing valuable insights into the potential benefits of this treatment approach for melanoma patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be asked to sign an informed consent form. This form confirms your understanding of the trial and your agreement to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of invasive cutaneous melanoma and ensuring you meet the age criteria of 18 to 80 years.
Step 3
Surgery preparation
You will be prepared for surgery, which involves a wide local excision and sentinel lymph node biopsy. This is a standard procedure for melanoma treatment.
Step 4
Medication administration
You will receive either tranexamic acid or a placebo. Tranexamic acid is administered as an intravenous infusion before surgery. The exact dosage and frequency will be determined by the medical team.
Step 5
Post-surgery follow-up
After surgery, you will be monitored for any immediate postoperative complications such as bleeding, seroma, or infection. Follow-up visits will be scheduled to assess your recovery and any potential side effects.
Step 6
Long-term monitoring
You will be monitored for up to five years to track your melanoma-specific survival and overall survival. This includes regular check-ups to detect any signs of relapse or metastasis.
Step 7
Completion of trial
The trial is expected to conclude by March 2028. At the end of the trial, the results will be analyzed to determine the effectiveness of tranexamic acid in reducing early relapse rates in melanoma patients.

Who can join the trial?

6 criteria

Patients must be diagnosed with invasive cutaneous melanoma. This means a type of skin cancer that has grown deeper into the skin.
The melanoma must be at a pathological stage or tumor grade higher than T2b. This refers to the size and extent of the tumor.
The Breslow thickness of the melanoma should be more than 1.0-2.0 mm with the presence of ulceration (a break on the skin) or more than 2.0 mm regardless of ulceration status.
Patients must be eligible for surgery, specifically wide local excision and sentinel lymph node biopsy. This means they can have the tumor and some surrounding tissue removed, and a nearby lymph node checked for cancer cells.
Patients must be aged 18 years or older and 80 years or younger.
Patients must have signed an Informed Consent Form, which means they understand the study and agree to participate.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with melanoma cannot participate. Melanoma is a type of skin cancer.
Patients who are not undergoing surgery for melanoma cannot participate. Surgery is a medical procedure to remove or repair a part of the body.
Patients who are not having a sentinel lymph node biopsy cannot participate. This is a procedure to check if cancer has spread to the lymph nodes.
Patients who are under 18 years old or over 65 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Herlev Hospital
Verified
Herlev, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

Trial locations

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Investigated drugs

Tranexamic Acid (TXA) is a medication used in this clinical trial to help reduce bleeding. It works by preventing the breakdown of blood clots, which can be particularly useful during and after surgery. In this study, the researchers are investigating whether using Tranexamic Acid around the time of surgery can lower the chances of melanoma coming back early after surgery. The goal is to see if this medication can improve outcomes for patients undergoing surgery for melanoma by reducing the risk of early relapse.

What is already known about the treatment

Tranexamic Acid (TXA) – Tranexamic Acid is administered orally or intravenously and is currently being studied for its potential benefits in reducing early relapse rates in melanoma patients undergoing surgery. It is primarily used to prevent excessive bleeding by helping blood to clot more effectively. At the molecular level, TXA works by blocking the breakdown of fibrin, a protein that helps form blood clots, thus stabilizing the clot and preventing bleeding. It is classified as an antifibrinolytic agent, which means it helps prevent the breakdown of blood clots.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new mole or a change in an existing mole, characterized by asymmetry, irregular borders, multiple colors, and a diameter larger than a pencil eraser. As melanoma progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease can advance from a localized stage to regional and then to distant metastasis, where cancer cells travel through the lymphatic system or bloodstream. Early stages may be confined to the skin, but as it progresses, it can invade deeper tissues and organs. The progression of melanoma is often categorized by stages, with each stage indicating the extent of spread and depth of tumor invasion.