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Study on Octreotide for Nutritional Recovery After Surgery in Esophageal or Gastric Cancer Patients

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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 patients with esophageal cancer and gastric cancer, which are types of cancer affecting the esophagus and stomach. The study is investigating the use of a treatment called octreotide, also known by its code name Debio 4126. Octreotide is administered as an injection into the muscle and is intended to help improve nutritional recovery after surgery for these cancers.

The purpose of the study is to determine if octreotide can help reduce weight loss after surgeries like gastrectomy or esophagectomy, which are procedures to remove part or all of the stomach or esophagus. Participants in the study will receive either octreotide or a placebo. The study will monitor participants over several months, checking their weight and other health indicators at regular intervals after surgery.

Throughout the study, various health aspects will be assessed, including body composition, quality of life, and the need for additional nutritional support. The study will also track any side effects experienced by participants, such as nausea or fatigue, to ensure the safety and effectiveness of the treatment. The trial aims to provide valuable insights into how octreotide can support recovery and improve outcomes for patients undergoing surgery for esophageal or gastric cancer.

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, the patient will have already signed an informed consent form, confirming understanding and agreement to participate in the trial.
The patient must have a confirmed diagnosis of esophageal or gastric cancer and have undergone surgery with the intent to cure the cancer.
Step 2
Initial assessment
Before starting the treatment, the patient's baseline weight will be recorded. This will serve as a reference point for measuring weight changes throughout the study.
Various health assessments will be conducted, including measurements of certain blood markers and body composition.
Step 3
Treatment administration
The patient will receive an injection of octreotide, a medication intended to help with nutritional recovery after surgery. The specific product used is called Sandostatin LAR 10 mg.
The injection is given into a muscle, a method known as intramuscular injection. The frequency and duration of the treatment will be determined by the study protocol.
Step 4
Follow-up assessments
The patient's weight will be monitored at 1, 2, 3, and 6 months after surgery to assess any changes.
Additional health assessments will be conducted at various intervals, including measurements of specific blood markers and evaluations of body composition and quality of life.
Step 5
Monitoring and reporting
Throughout the study, any side effects or adverse events experienced by the patient will be recorded. These may include symptoms such as nausea, fatigue, or pain at the injection site.
The need for additional nutritional support, such as feeding tubes, will also be assessed.
Step 6
Completion of the study
At the end of the study period, a final assessment will be conducted to evaluate the overall impact of the treatment on the patient's nutritional recovery and quality of life.
The study is expected to conclude by June 2025, at which point all data will be analyzed to determine the effectiveness of the treatment.

Who can join the trial?

8 criteria

Diagnosis of esophageal or gastric cancer confirmed by a special test called pathologic anatomic analysis (PAD).
Undergoing surgery called gastrectomy or esophagectomy with the goal of curing the cancer.
Must be 18 years of age or older.
Must have signed a document called informed consent, which means you understand the study and agree to participate.
Must be able to follow the study procedures, as determined by the study doctor.
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Women who can become pregnant must meet the following conditions:
- Have a negative pregnancy test before starting the study.
- Use a highly effective method of birth control during the study. These methods have a failure rate of less than 1% per year when used correctly.
- Take another pregnancy test at the end of the study.

Who cannot join the trial?

7 criteria

Patients who have not been diagnosed with esophageal or gastric cancer cannot participate.
Patients who are not within the specified age range cannot participate. The study is open to adults and older adults.
Patients who are not able to give informed consent or understand the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who have had a recent surgery or are planning to have surgery soon cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

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Verified sites

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Karolinska University Hospital
Solna, Sweden

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Investigated drugs

Octreotide is a medication used in this clinical trial to help patients recover better after surgery for esophageal or gastric cancer. It is given as an injection into the muscle. The main goal of using octreotide in this study is to see if it can help reduce weight loss that often happens after surgeries like gastrectomy or esophagectomy, which are procedures to remove parts of the stomach or esophagus affected by cancer. By potentially reducing weight loss, octreotide may help improve the overall nutritional recovery of patients after their surgery.

Octreotide

What is already known about the treatment

Octreotide – Octreotide is administered through an injection into the muscle, known as intramuscular administration. It is currently being studied in clinical trials to see if it can help patients recover better after surgery for esophageal or gastric cancer by reducing weight loss. The main therapeutic use being explored is to support nutritional recovery after major cancer surgeries. At the molecular level, octreotide works by mimicking a natural hormone in the body that reduces the release of certain digestive hormones, which can help manage symptoms and improve recovery. It is classified as a somatostatin analog in pharmacology.

Investigated diseases

Esophageal and gastric cancer – Esophageal cancer is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells lining the esophagus and can progress by invading deeper layers and spreading to nearby structures. Gastric cancer, also known as stomach cancer, starts in the stomach lining and can grow through the stomach wall, potentially spreading to nearby organs. Both cancers can cause symptoms like difficulty swallowing, weight loss, and digestive issues as they progress. They may also lead to changes in appetite and nutritional deficiencies due to their impact on the digestive system. As these cancers advance, they can affect the body's ability to process food and absorb nutrients effectively.