Active not recruitingPHASE2INTERVENTIONAL

LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

This study is investigating a new approach to chemotherapy for people with Stage III colon cancer. Currently, chemotherapy doses are often calculated based on a person's total body surface area. However, this study suggests that basing the dose on a person's lean body mass (muscle) rather than overall size might be better. The idea is that patients with less muscle might be 'overdosed' with standard chemotherapy, leading to more severe side effects, especially nerve damage. By adjusting the dose to lean body mass, the researchers hope to reduce these unpleasant side effects, allowing patients to complete their treatment more comfortably and effectively. This Phase 2 trial aims to see if this new dosing method is safe and effective in preventing nerve problems associated with oxaliplatin chemotherapy.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

160

Start

01 Nov 2017

Estimated completion

31 Jul 2025

Stage III Colon Cancer

What is this study about?

When someone has Stage III colon cancer, doctors often recommend chemotherapy that includes a drug called oxaliplatin. This treatment aims to kill any remaining cancer cells after surgery. While it's very effective at fighting cancer, oxaliplatin can cause unpleasant side effects, particularly nerve damage (neuropathy) that can sometimes be long-lasting or even permanent. This nerve damage can lead to tingling, numbness, or pain, and can make everyday activities difficult.

Currently, the amount of chemotherapy a person receives is usually worked out based on their total body size, specifically their body surface area. However, every person's body is different – some people have more muscle, and some have more fat. This study is exploring the idea that focusing on a person's *lean body mass* (how much muscle they have) might be a better way to decide the chemotherapy dose. Researchers believe that if a person has less muscle, the standard dose might be too strong for them, leading to more severe side effects, even if their overall body size is average.

The main goal of this study is to see if adjusting the oxaliplatin dose based on a person's lean body mass can reduce these problems, especially nerve damage. By giving a dose that's more tailored to an individual's muscle mass, doctors hope to make the treatment safer and more comfortable, allowing more patients to complete their full course of chemotherapy without needing to reduce their dose or stop treatment early due to side effects.

Key takeaways

This study is testing a new way to give chemotherapy for Stage III colon cancer.
The new method adjusts chemotherapy dose based on your muscle (lean body mass), not just overall size.
The aim is to reduce side effects, especially nerve damage, from oxaliplatin chemotherapy.
Participants will receive standard oxaliplatin-based chemotherapy for 6 months.
The study hopes to make treatment safer and more comfortable for patients.
Your decision to participate is voluntary and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 75 years old and have been diagnosed with Stage III colon cancer. You must have had surgery to remove the cancer and be scheduled to start a specific type of oxaliplatin-based chemotherapy (called 'simplified FOLFOX 4') for six months. Your blood test results, which check your overall health, kidney, and liver function, must be within certain healthy limits, and you should be generally well enough to undergo chemotherapy.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have existing nerve damage. If you have been treated with certain other chemotherapy drugs in the past, or if you are taking specific medications for conditions like epilepsy or depression, you might not be able to participate. Women who could become pregnant and men must agree to use reliable contraception during the study.

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 between 18 and 75 years old?
Do you have Stage III colon cancer and have had surgery?
Are you scheduled to receive oxaliplatin-based chemotherapy?
Are your general blood test results (e.g., blood counts, kidney/liver function) within a healthy range?
Do you *not* have existing problems with nerve damage?
Are you willing to use reliable contraception if you could become pregnant or have children?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive chemotherapy that includes oxaliplatin for six months, just like the standard treatment for Stage III colon cancer. The main difference is that your oxaliplatin dose might be adjusted based on your lean body mass rather than your total body size. You will have regular visits to the hospital for your chemotherapy treatments and check-ups. During these visits, doctors and nurses will monitor your health closely, including regular blood tests and neurological examinations to check for any nerve damage. You may also be asked to complete questionnaires about how you are feeling. Throughout the study, you'll provide blood samples for research purposes. The total duration of active treatment and follow-up will depend on your chemotherapy schedule and how your doctors monitor your progress after treatment, but the chemotherapy itself is planned for six months.

Potential risks and benefits

Taking part in this study means you will receive cancer treatment which carries known risks, mainly various side effects like fatigue, nausea, and the possibility of nerve damage, though this study aims to reduce that specific risk. There is no guarantee you will personally benefit from being in the study, but the information gathered could help improve chemotherapy for future patients by finding a way to reduce side effects. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (11)

Hôpital Européen
Verified postcode
Marseille, France
Centre hospitalier régional et universitaire de Montpellier
Verified postcode
Montpellier, France
CHU de Nancy
Verified postcode
Vandœuvre-lès-Nancy, France
Insitut de Cancérologie de Lorraine
Verified postcode
Vandœuvre-lès-Nancy, France
Hôpital Saint-Jean
Verified postcode
Perpignan, France
Centre François Baclesse
Verified postcode
Caen, France
CHU La TIMONE
Verified postcode
Marseille, France
Institut regional du Cancer - Val d Aurelle
Verified postcode
Montpellier, France
AP-HP Hôpital Saint-Louis
Verified postcode
Paris, France
Centre Eugène Marquis
Verified postcode
Rennes, France
Centre Paul Strauss
Verified postcode
Strasbourg, France

Common questions

What is 'Stage III Colon Cancer'?

Stage III colon cancer means the cancer has spread beyond the first layers of the colon wall and into nearby lymph nodes, but has not yet spread to distant parts of the body.

What is oxaliplatin?

Oxaliplatin is a chemotherapy drug commonly used to treat colorectal cancer. It works by damaging cancer cells to stop them from growing and dividing.

What does 'lean body mass' mean?

Lean body mass is essentially everything in your body except fat. It includes your muscles, bones, organs, and water. This study is looking at adjusting drug doses based on this muscle and non-fat tissue.

What is nerve damage (neuropathy) from chemotherapy?

Nerve damage from chemotherapy often causes tingling, numbness, pain, or weakness, usually in the hands and feet. It can sometimes affect daily activities and persist after treatment stops.

Will I know if my dose is being adjusted?

Yes, if you participate, the research team will explain how your chemotherapy dose is determined and if it is being adjusted based on your lean body mass as part of the study.