Study on Metformin for Patients with Esophageal Cancer to Enhance Chemoradiotherapy Response

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What is this study about?

This clinical trial is focused on studying oesophageal adenocarcinoma, a type of cancer that occurs in the esophagus. The study will use a medication called Metformin Aurobindo, which is a 500 mg film-coated tablet. Metformin is commonly used to treat diabetes, but in this study, it is being tested to see if it can help improve the body’s response to cancer treatment. The purpose of the study is to explore whether taking metformin for two weeks can activate the immune system within the tumor, potentially making the cancer more responsive to treatment.

Participants in the study will take metformin orally, which means they will swallow the tablets. The study will involve taking metformin for a short period of two weeks. During this time, researchers will collect information by comparing tumor samples taken before and after the treatment. This will help them understand if there are any changes in the immune cells within the tumor, specifically looking at certain types of cells called macrophages and T cells. These cells play a role in the body’s defense against cancer.

The study will also monitor other aspects, such as any side effects experienced by participants and how the cancer responds to treatment over time. The goal is to see if metformin can make the cancer treatment more effective and improve outcomes for patients with oesophageal adenocarcinoma. This research could provide valuable insights into new ways to enhance cancer treatment by using existing medications like metformin.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must provide written, voluntary informed consent to participate.

The patient must meet specific criteria, including being an adult aged 18 or older, having a surgical resectable oesophageal adenocarcinoma, and having adequate blood, kidney, and liver function.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

The patient must be willing to undergo two endoscopies for investigational purposes.

3 medication administration

The patient will begin taking Metformin Aurobindo 500 mg film-coated tablets orally. The dosage and frequency will be determined by the study protocol.

The treatment with metformin will last for 2 weeks.

4 monitoring and follow-up

During the treatment period, the patient will be monitored for any side effects or adverse events. This will be assessed using the Common Toxicity Criteria for Adverse Events (CTCAE).

The patient will have follow-up visits to evaluate the response to the treatment and to monitor overall health.

5 end of treatment evaluation

After completing the 2-week treatment, the patient will undergo a post-treatment evaluation. This includes a second endoscopy to assess changes in the tumour.

The primary objective is to determine if the treatment has activated the tumour’s immune environment, specifically looking at changes in certain immune cells.

6 long-term follow-up

The patient will continue to be monitored for progression-free survival and overall survival.

Additional assessments may include measuring changes in immune cell infiltration and metabolic changes within the tumour environment.

Who Can Join the Study?

Patients must have a type of cancer called oesophageal adenocarcinoma, which affects the esophagus.
The cancer must be surgically resectable, meaning it can be removed through surgery.
Patients must be adults, aged 18 years or older.
Patients should have an ECOG performance status of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Patients need to have adequate blood, kidney, and liver function, which includes:
- Absolute Neutrophil Count of at least 1.5 x 10⁹/L. Neutrophils are a type of white blood cell important for fighting infections.
- Platelets of at least 100 x 10⁹/L. Platelets help with blood clotting.
- Haemoglobin of at least 5.6 mmol/L. Haemoglobin is a protein in red blood cells that carries oxygen.
- Total bilirubin of no more than 1.5 times the upper normal limit. Bilirubin is a substance made during the normal breakdown of red blood cells.
- Creatinine clearance greater than 30 ml/min. This measures how well the kidneys are working.
Patients must agree to have two endoscopies for research purposes. An endoscopy is a procedure where a doctor uses a flexible tube with a camera to look inside the body.
Patients must provide written, voluntary informed consent, meaning they agree to participate after understanding the study details.
Patients must be able to return to the treatment center for follow-up and management.

Who Cannot Join the Study?

Patients who are not diagnosed with oesophageal adenocarcinoma, which is a type of cancer in the tube that connects the throat to the stomach.
Patients who are not within the specified age range for the study.
Patients who belong to a clinical trial group that is not included in this study.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Dijklander Ziekenhuis	Hoorn	The Netherlands
Aemzwgqfb Uel	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Metformin Hydrochloride

Metformin is a medication commonly used to treat type 2 diabetes. In this clinical trial, it is being investigated for its potential to activate the immune environment within tumors. The study aims to see if metformin can change certain immune cells in the tumor, which might help improve the effectiveness of other cancer treatments.

Investigated diseases:

Oesophageal adenocarcinoma

Oesophageal adenocarcinoma – This is a type of cancer that forms in the glandular cells of the esophagus, which is the tube that carries food from the throat to the stomach. It typically begins in the lower part of the esophagus and is often associated with chronic acid reflux or Barrett’s esophagus. As the disease progresses, the cancer cells can invade deeper layers of the esophagus and may spread to nearby lymph nodes and other organs. Symptoms may include difficulty swallowing, chest pain, and weight loss. The progression of the disease can lead to narrowing of the esophagus, making it difficult for food to pass through. Early detection is crucial for managing the disease effectively.

Trial ID:

2024-511626-30-00

Protocol code:

MEMENTO

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Metformin for Patients with Esophageal Cancer to Enhance Chemoradiotherapy Response

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?