
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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 is damaged and the lymphatic fluid does not drain properly.
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.
You can enter this trial if you
You cannot enter this trial if you
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 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.
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
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 of compression treatment can include
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Christine Moffatt
NIHR Clinical Research Network: Cancer
Tactile Systems Technology
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”