RecruitingPHASE3INTERVENTIONAL

Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

This study is investigating if a tailored exercise programme, known as Adapted Physical Activity (APA), can improve the health and outlook for older patients (65 and above) with a common type of blood cancer called diffuse large B-cell lymphoma (DLBCL). DLBCL affects white blood cells and is often treated with chemotherapy called R-CHOP. While many patients are cured, some sadly relapse. Researchers believe that APA, possibly combined with good nutrition, could help reduce muscle weakness (called sarcopenia) which can make treatment harder and affect how well patients do. The study aims to see if adding APA to standard chemotherapy helps patients live longer without their cancer returning, compared to chemotherapy alone.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Weprom

Enrolment target

186

Start

08 Sep 2021

Estimated completion

01 Feb 2029

Diffuse Large B Cell Lymphoma

What is this study about?

This study is about a common type of cancer called diffuse large B-cell lymphoma (DLBCL). It's a cancer that affects certain white blood cells and is the most common kind of non-Hodgkin lymphoma. Most people who get it are over 65. While many patients respond well to standard chemotherapy treatment called R-CHOP, about 40% (4 out of 10) unfortunately see their cancer come back.

Researchers have found that things like losing muscle mass and strength, known as sarcopenia, can make it harder for patients to recover and might lead to worse outcomes. Sarcopenia is more common as people get older and can be made worse by cancer and chemotherapy. However, studies suggest that physical activity and good nutrition might help reduce this muscle loss and improve how patients cope with their illness.

This study wants to find out if adding a special exercise programme, called Adapted Physical Activity (APA), to standard R-CHOP chemotherapy can make a real difference for these patients. The main goal is to see if patients who do APA along with their treatment will live longer without their cancer returning, compared to those who only receive chemotherapy.

Key takeaways

This study is for patients aged 65 or older with a common lymphoma type.
It investigates if tailored exercise improves cancer outcomes.
The goal is to increase the time patients live without their cancer returning.
Physical activity could help combat muscle weakness often seen with treatment.
Participation involves adapted exercise alongside standard chemotherapy.

Who may be eligible?

This study is looking for people aged 65 or older who have been diagnosed with diffuse large B-cell lymphoma (DLBCL), or another type of slow-growing lymphoma that has changed into a DLBCL. To join, you should be starting treatment with R-CHOP chemotherapy or have had no more than two cycles of it already.

Your general fitness level should be good enough to take part in exercise, and you shouldn't have major heart, lung, or joint problems that would stop you from exercising safely. You also can't be pregnant or breastfeeding, have certain active infections, or have a mental condition that would make it difficult to understand the study. Importantly, you shouldn't have already had three or more cycles of your first round of chemotherapy.

There are also some other specific medical conditions that might mean you can't join, such as certain brain conditions related to your cancer or other types of lymphoma. The study team will check all these details carefully with you.

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 65 years old or older?
Have you been diagnosed with diffuse large B-cell lymphoma?
Are you about to start or have you recently started R-CHOP chemotherapy (no more than 2 cycles)?
Are you generally fit enough to do some form of exercise?
Do you have any major heart, lung, or joint problems that stop you from exercising?
Are you free from serious active infections like Hepatitis B/C or HIV?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely be asked to be more physically active as part of the Adapted Physical Activity (APA) programme, alongside your regular chemotherapy. This might involve specific exercises tailored to your abilities. The study will carefully monitor your health and how you respond to treatment, and this will involve regular check-ups and assessments by the study team. They will explain the exact duration of the APA programme and how long you will be followed up after your treatment finishes. All details about visits, tests, and how long you'll be involved will be clearly explained before you agree to join.

Potential risks and benefits

Taking part in this study might offer the benefit of potentially improving your health and how well you respond to treatment by adding adapted exercise. However, as with any exercise program, there's always a small risk of muscle soreness or injury, though the programme will be tailored to your abilities to minimise this. There are no guarantees that this particular exercise programme will be effective for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

CHU Jean Minjoz
Verified postcode
Besançon, France· Not yet recruiting
Clinique Victor Hugo / Centre Jean Bernard
Verified postcode
Le Mans, France· Recruiting
CHRU Nancy
Verified postcode
Nancy, France· Not yet recruiting
Hôpital Privé du Confluent
Verified postcode
Nantes, France· Recruiting
CH Perpignan
Verified postcode
Perpignan, France· Recruiting

Common questions

What is diffuse large B-cell lymphoma?

It's a common and fast-growing type of cancer that affects white blood cells called B lymphocytes, which are part of your immune system.

What is Adapted Physical Activity (APA)?

It's a specially designed exercise programme tailored to your individual needs and abilities, often supervised by professionals, to help you stay active safely.

What is sarcopenia?

Sarcopenia is when you lose muscle mass and strength, which can be linked to ageing, illness, and medical treatments like chemotherapy.

Will I still get my usual cancer treatment?

Yes, you will still receive your standard R-CHOP chemotherapy treatment, this study is looking at adding APA alongside it.

What if I can't do much exercise?

The APA programme is 'adapted,' meaning it will be designed to suit your current fitness level and any physical limitations you may have.

How to find out more

Magali BALAVOINE

m.balavoine@weprom.fr 0241682940 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.