AuthorisedTherapeutic exploratory (Phase II)Interventional

LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

This research study is for people with colon cancer and is called LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy. It's a Phase II study, meaning it's still in the early stages of finding out if a new way of giving treatment is safe and works well. The main idea is to customise chemotherapy doses based on how much lean muscle and bone a person has, rather than their total body weight. Current chemotherapy doses are usually based on overall body size, but this study wants to see if a more tailored approach might make the treatment more effective and cause fewer side effects for people with colon cancer. Researchers hope this method could lead to better outcomes for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Regional Du Cancer De Montpellier

Enrolment target

160

Start

22 Aug 2024

Colon cancer

What is this study about?

This study is about making chemotherapy for colon cancer more effective and comfortable for patients. Chemotherapy drugs are often given based on a person's total body size. However, what if the amount of muscle and bone a person has (their 'lean body mass') is a better guide for how much medicine they truly need?

That's exactly what this study, called LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy, is exploring. It's designed to see if giving people with colon cancer a chemotherapy dose that's adjusted to their lean body mass works better than the usual method. The hope is that by being more precise, the treatment might work better against the cancer and also lead to fewer unwanted side effects.

This is an important step in finding new and improved ways to treat colon cancer. If successful, this research could change how chemotherapy is given in the future, making it a more personalised and potentially more effective treatment for many people.

Key takeaways

This study explores a new way to give colon cancer chemotherapy.
It aims to tailor chemotherapy doses based on your muscle and bone (lean body mass).
The goal is to improve treatment effectiveness and reduce side effects.
It's a Phase II study, meaning an earlier stage of research.
Participation involves receiving chemotherapy and regular health checks.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 years or older, with a diagnosis of colon cancer. The study is open to both men and women.

The researchers will also look at other specific details about your health and your cancer to make sure the study is a good fit for you and that you can safely take part. For example, they'll check if you're healthy enough for the treatment being studied and if you have any other medical conditions that might make participating unsafe or complicate the results.

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 colon cancer?
Are you able to attend regular hospital appointments?
Have you discussed this study with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive chemotherapy for your colon cancer as part of the research. Instead of the usual way of calculating your dose, the doctors will measure your lean body mass (how much muscle and bone you have) to decide the exact amount of medicine you'll receive. You will have regular appointments for your chemotherapy treatments, which usually involves visits to the hospital.

During your time in the study, you'll have appointments where doctors and nurses will check your health, give you blood tests, and ask about how you're feeling and any side effects you might be having. This helps them monitor your progress and safety. The total length of your participation will depend on your treatment plan, but it will involve a series of treatment cycles and follow-up checks afterwards to see how you are doing.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a more tailored and potentially more effective chemotherapy treatment for your colon cancer, possibly with fewer side effects than usual dosing. However, as with any medical treatment, there are potential risks, including side effects from the chemotherapy medicines. These side effects can vary from person to person. You will be closely monitored for any problems. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is 'lean body mass'?

Lean body mass is essentially everything in your body except fat. It includes your muscles, bones, and organs.

Why is this study looking at lean body mass for chemotherapy?

The study wants to see if adjusting chemotherapy doses based on lean body mass rather than total body weight can make the treatment more effective and reduce side effects.

What phase is this study in?

This is a Phase II study. This means it's an early-stage study to see if a new treatment approach is safe and works well before it's compared to standard treatments in larger studies.

Will I still receive treatment for my colon cancer if I join the study?

Yes, if you join, you will receive chemotherapy treatment for your colon cancer as part of the study, but the way your dose is calculated will be different.

Can I leave the study once I've joined?

Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.