Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Octreotide treatment to improve nutritional recovery after surgery for patients with esophageal or gastric cancer, a prospective randomized open label phase II study - OTIS

This research study, called OTIS, is investigating if a medication called octreotide, given after surgery for esophageal (gullet) or stomach cancer, can help patients recover their weight. Many people lose a lot of weight after these types of surgeries, and the study aims to see if octreotide can reduce this weight loss. Researchers will follow participants for six months, regularly checking their weight. They will also look at other things like how the treatment affects their overall well-being, body fat, and whether they need feeding tubes. Safety is very important, so researchers will carefully record any side effects experienced by patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Karolinska University Hospital

Enrolment target

172

Start

20 Dec 2022

Esophageal and gastric cancer

What is this study about?

For people who have had surgery for cancer of the gullet (esophagus) or stomach, losing weight can be a big challenge. This weight loss can make recovery harder and affect how well people feel. This study, called OTIS, is designed to see if a specific medication, octreotide, can help reduce this weight loss and improve recovery after surgery.

Imagine your body's natural systems that control how you digest food and gain or lose weight. Sometimes, after major surgery like this, these systems don't work as smoothly. Octreotide is a drug that can affect some of these systems, and doctors want to find out if it can help stabilize weight after surgery. This is a "Phase II" study, which means it's one of the earlier steps in testing a new treatment – it's about seeing if it works and what the right dose might be, rather than comparing it to a widely used treatment.

The main thing the researchers want to find out is how much weight people lose over six months after surgery while taking octreotide. But they're also interested in many other aspects of recovery. They will check things like body fat, how people are feeling day-to-day (their quality of life), and if they need extra feeding through tubes. They will also carefully monitor any side effects from the medication.

Key takeaways

This study investigates octreotide to help weight recovery after esophageal/stomach cancer surgery.
It's a Phase II study, meaning it's exploring if the treatment works and is safe.
Participation involves receiving injections and regular check-ups for six months.
Researchers will monitor weight, overall well-being, body fat, and potential side effects.
The goal is to improve nutritional recovery for patients after this type of surgery.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged at least 18 years old. The study is open to both men and women.

Crucially, you would need to have been diagnosed with cancer of the esophagus (gullet) or stomach and be scheduled to have surgery for this condition. The study will then provide the medication and monitor your recovery in the months following that surgery.

There might be other specific health requirements or conditions that could mean you wouldn't be able to join, or vice-versa. Your doctor will be able to check these in detail against your medical history.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with cancer of the gullet (esophagus) or stomach?
Are you scheduled to have surgery for this cancer?
Are you able to attend follow-up appointments for six months?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medication, Sandostatin LAR, which is given as an injection. This medication will be given after your surgery for esophageal or stomach cancer. You'll have several follow-up appointments and assessments after your surgery, at 1, 2, 3, and 6 months. During these visits, researchers will measure your weight, and you'll answer questions about your health and how you're feeling using special questionnaires. They will also take blood samples to measure certain hormone levels and check your body composition. The total duration of active participation, including check-ups, would be about six months.

Potential risks and benefits

Taking part in this study may offer the potential benefit of better weight recovery after your surgery, which could improve your overall well-being. However, there's also the chance the octreotide might not help, or you might experience known side effects of the medication. These can include stomach upset (like nausea, abdominal pain, constipation), headaches, fatigue, and issues with blood sugar or injection site pain. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Sweden

Common questions

What is octreotide and how is it given?

Octreotide is a medication given as an injection, designed to help with certain body processes like digestion and hormone control after surgery.

Why is this study being done?

The study aims to see if octreotide can help people with esophageal or stomach cancer keep their weight up after surgery, which can be a big challenge for many.

How long will I be involved in the study?

If you join, you will be followed and monitored for about six months after your surgery.

Will I still get my usual cancer care?

Yes, joining this study is in addition to your standard cancer treatment and care, which will continue as planned by your medical team.

Are there any side effects from the study drug?

Like most medications, octreotide can have side effects. These can include stomach problems, headaches, fatigue, or discomfort where the injection is given. These will be carefully monitored.