A study of peginterferon alfa-2a to improve immune system function during colon cancer surgery

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What is this study about?

This clinical trial focuses on patients with colon cancer who are scheduled for surgery. The study examines how Peginterferon alfa-2a (also known as Pegasys) affects the immune system during and after the surgical procedure. The medication is given through subcutaneous injection, which means it is injected under the skin.

The study compares two groups of patients – one receiving Peginterferon alfa-2a and another receiving placebo. The treatment involves giving the medication at specific doses before and after the surgical procedure. During the study, patients will receive either the study medication or placebo for up to 14 days. The study also includes the use of sodium chloride solution as part of the treatment.

The main purpose of this research is to understand how this medication affects certain immune cells in the body and within the tumor tissue during the surgical period. The study will examine how the immune system responds to the treatment by looking at different types of immune cells in both the blood and the removed tumor tissue.

1 Initial treatment phase

You will receive a subcutaneous injection (under the skin) of either Pegasys (peginterferon alfa-2a) or a placebo solution

The injection contains 135 micrograms of the medication in a pre-filled syringe

This treatment is administered before your scheduled laparoscopic hemicolectomy (minimally invasive colon surgery)

2 Surgery day

Blood samples will be collected to analyze your immune cell levels

Your scheduled laparoscopic hemicolectomy will be performed

During surgery, you will receive standard sodium chloride solution (saline) through an intravenous line

3 Day after surgery

Additional blood samples will be collected to monitor immune cell levels

Your recovery will be monitored by medical staff

4 Third post-operative day

You will complete a Quality of Recovery questionnaire about your recovery experience

5 12-16 days after surgery

Final Quality of Recovery questionnaire completion

Assessment of your recovery progress

6 Follow-up period

Regular monitoring until the study conclusion in December 2026

Analysis of tissue samples from surgery will be performed to study immune cell patterns

Who Can Join the Study?

  • You must be 18 years or older
  • You must be diagnosed with colon cancer specifically of the type called pMMR colonic adenocarcinoma (a common type of colon cancer that has normal DNA repair mechanisms)
  • You must be scheduled for laparoscopic hemicolectomy (a minimally invasive surgery to remove part of the colon)
  • Your physical health status must fall within ASA class I-III (a scale used by doctors to assess a patient’s health before surgery, where:
    • Class I means you are healthy
    • Class II means you have mild systemic disease
    • Class III means you have severe systemic disease)
  • Both men and women can participate

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Known allergy or hypersensitivity to study medications
  • Currently participating in other clinical trials
  • Previous surgery for colon cancer
  • History of other cancers in the past 5 years (except non-melanoma skin cancer)
  • Severe heart, liver, or kidney disease
  • Active infection or fever
  • Pregnancy or breastfeeding
  • Use of immunosuppressive medications (drugs that weaken the immune system)
  • Autoimmune diseases (conditions where the immune system attacks the body’s own tissues)
  • Mental conditions that could affect ability to provide informed consent
  • Blood disorders or abnormal blood cell counts
  • Inability to follow study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Region Sjaelland Holbæk Denmark
Hwvbgi Huuegjen Herlev Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.08.2023

Trial locations

Interferon-alfa2a is a medication that helps boost the immune system. It belongs to a group of proteins called interferons that naturally occur in the body. In this trial, it is used in a low dose to prevent the weakening of the immune system that typically occurs during and after surgery. The medication works by helping to maintain the number and function of important immune cells, particularly different types of white blood cells that help fight diseases.

Investigated diseases:

Colon Cancer – A disease that begins in the large intestine (colon), where healthy cells in the colon start to grow uncontrollably. It typically starts as small, benign clumps of cells called polyps that form on the inner lining of the colon. Over time, some of these polyps can develop into colon cancer. The disease usually develops slowly, which means it takes several years for a polyp to transform into cancer. As the condition progresses, cancer cells can grow through the layers of the colon wall and potentially spread to nearby structures or other parts of the body. The cancer can affect any part of the colon, which is the final part of the digestive tract before the rectum.

Trial ID:
2024-517619-65-00
Trial Phase:
Therapeutic exploratory (Phase II)

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