Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Prophylaxis of venous thromboembolic disease with LMWH (TINzaparin) in patients with metastatic colorectal cancer who start the first line of treatment.

This research is investigating if a medicine called tinzaparin, which helps prevent blood clots, can be beneficial for people with advanced bowel or rectal cancer. These are cancers that have spread to other parts of the body (Stage IV). The study focuses on patients who are about to begin their initial course of cancer treatment. Researchers want to see if tinzaparin can effectively reduce the chances of developing various types of blood clots, such as those in the lungs, legs, or arms, and also clots that might form around central lines or in tummy organs. The study will carefully track how many people develop these clots to understand if tinzaparin offers a protective effect.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Grupo Gallego De Investigacion En Tumores Digestivos

Enrolment target

631

Start

16 Nov 2023

Stage IV colon or rectal adenocarcinoma (mCRC).

What is this study about?

This clinical trial is designed to investigate a specific medicine called tinzaparin. Tinzaparin is a type of 'blood thinner' that doctors sometimes use to prevent blood clots. Blood clots can be a serious problem for some people, especially those with certain health conditions like advanced cancer.

For people with advanced bowel or rectal cancer (meaning the cancer has spread), there can be a higher risk of developing blood clots. These clots can happen in different parts of the body, like the legs (deep vein thrombosis or DVT) or the lungs (pulmonary embolism or PE), and can sometimes be very serious. This study wants to find out if giving tinzaparin to patients with advanced bowel cancer right when they start their first cancer treatment can help lower their risk of getting these clots.

By carefully watching a large group of patients, the researchers hope to understand if tinzaparin is an effective way to prevent these blood clots from forming. This could potentially help improve the safety and well-being of people going through treatment for advanced bowel cancer.

Key takeaways

This study explores blood clot prevention in advanced bowel/rectal cancer.
It uses a blood-thinning medicine called tinzaparin.
The focus is on patients starting their first cancer treatment.
Aims to reduce serious clots in legs, lungs, and other parts of the body.
Participants must be 18+ with advanced bowel cancer.
Learning more could improve care for these patients.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part.

The main health condition for this study is having advanced bowel or rectal cancer. This means the cancer has spread to other parts of your body. You would also need to be just starting your very first course of treatment for this advanced cancer.

The research team will have a full list of things they check to make sure the study is right and safe for you. This often includes looking at your other medical conditions and any medicines you are already taking.

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?
Do you have advanced bowel or rectal cancer (cancer that has spread)?
Are you about to start your very first treatment plan for this advanced cancer?
Are you open to using a 'blood-thinning' injection as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, tinzaparin, which is given as an injection. The injections come in pre-filled syringes. You would have regular check-ups and assessments with the study team. These visits would involve monitoring your health, checking for any side effects, and looking at how the treatment is working. The study is designed to follow you for a specific period to see the long-term effects on preventing blood clots. The exact number of visits, how often they are, and the total duration would be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that tinzaparin might help prevent serious blood clots, which could improve your health outcomes. However, like all medicines, tinzaparin can have side effects, such as a higher risk of bleeding, and these will be carefully explained to you. The study team will monitor you closely for any issues. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Portugal

Common questions

What is tinzaparin?

Tinzaparin is a medicine often called a 'blood thinner' because it helps prevent blood clots from forming.

Why are blood clots a concern with advanced cancer?

People with advanced cancer can sometimes have a higher risk of developing blood clots, which can be serious if they form in places like the legs or lungs.

What kind of cancer is this study for?

This study is for people with advanced bowel or rectal cancer, meaning the cancer has spread to other parts of the body.

Do I have to take part if I'm asked?

No, taking part in any study is entirely your choice. You can say no, or withdraw at any time, without it affecting your medical care.

Will I know if I'm getting the active medicine?

In some studies, participants may not know if they are receiving the study medicine or a comparison. The study team will explain how this works if you are suitable to join.