A trial comparing different ways of treating leg lymphoedema (ACE)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Other

This trial is looking at 2 pumps that help to drain lymph fluid for people with leg swelling (lymphoedema). Doctors call the pumps compression devices.

Lymphoedema can be a side effect of some cancer treatments including surgery and radiotherapy. It develops when the lymphatic system Open a glossary item is damaged and the lymphatic fluid does not drain properly.

More about this trial

Lymphoedema Therapists may treat lymphoedema with bandages or stockings that put pressure on the legs and help to stop fluid build up (compression bandages or stockings). They may also use gentle massage (manual lymphatic drainage). People can be taught how to continue these treatments at home. But it can take a long time and you may need treatment every day.

These treatments can help to reduce the swelling but will not cure it.

Compression pumps that you use at home aim to reduce the swelling for a longer period of time. This study will compare 2 different pumps. The people taking part continue to have their planned treatment for lymphoedema as well as using the pump.

The aim of the trial is to see which of the 2 pumps reduces swelling the most.

Who can enter

You can enter this trial if you

Have leg swelling which has been diagnosed as lymphoedema (which is not relieved by changing the position of your leg) - your doctor will discuss this with you
Are at least 18 years old

You cannot enter this trial if you

Have been diagnosed with cancer in the last 3 months, or your cancer was diagnosed in the past but has come back in the last 3 months
Have had surgery, chemotherapy or radiotherapy in the last 3 months
Had your first treatment for lymphoedema less than 3 months ago
Have had an infection that needed treatment in the last 2 weeks
Have had a blood clot in your lung (pulmonary embolism) in the last 6 months
Have had a blood clot in your leg (deep vein thrombosis) in the last 6 months
Are already taking part in a trial
Have had inflammation of a vein (thrombophlebitis) in the last 2 months (your doctor can advise you about this)
Have another serious medical condition that could affect you taking part in the trial
Have a waist measurement of more than 167cm, a hip measurement of more than 195cm, a measurement around your thigh of more than 89cm, or around your ankle of more than 56cm
Are pregnant

Trial design

This is a randomised trial. It will recruit 262 people in the UK and the USA. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your therapist will be able to decide which group you are in.

People in both groups have the standard treatment Open a glossary item of compression bandages or stockings and massage (manual lymphatic drainage) as well as treatment with one of the compression pumps.

Pump 1 is called a Flowtron Hydroven and works using an inflatable compression stocking on your leg that is inflated to help drain the lymph fluid.

Pump 2 is called a Flexitouch and works in a similar way to pump 1 but also helps drain fluid away from your tummy (abdomen) as well as your leg.

Treatment with either pump takes about an hour every day. You have the treatment for 6 months.

Even if the compression pump helps you, you may not be able to continue using it after the end of the trial. The study team will discuss this with you.

Hospital visits

Before starting treatment, a member of the trial team will measure your legs and make sure you have a well fitting compression stocking or bandage. They will give you instructions about how to use the pump. You will keep a daily diary about using the pump and your other treatments.

When you start using the pump, you see the trial team after a week, one month, 2 months, 3 months and 6 months.

At each visit they will

Measure both your legs
Find out how you are coping with the pump
Ask if you have any new health problems or have seen a doctor since your last visit

You will be asked to fill out a questionnaire before starting treatment, and after 3 and 6 months. The questionnaire will ask about how you have been feeling and how the swelling affects your day to day living. This is called a quality of life study.

Some people have an ultrasound scan and a local tissue water assessment at each visit. A tissue water assessment is like an ultrasound scan and is not painful. The study team will explain more about this test.

Side effects

Side effects of compression treatment can include

Pain in the toes, foot or lower leg
Cool, numb, white toes

These are usually due to the stocking or bandage being too tight (too much compression). You will be able to contact the trial team if you are having problems with side effects.