“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study to understand more about breast cancer related lymphoedema
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at why some women develop a swelling of the arm called lymphoedema (pronounced lim-fa-dee-ma), a few months or years after surgery for breast cancer. Most cases of lymphoedema happen within 3 years of the surgery. Researchers are trying to understand how the drainage of tissue fluid from the arm goes wrong in lymphoedema and why some women get it but most do not.
This study is supported by Cancer Research UK.
More about this trial
Tissue fluid is produced constantly and comes from the very small
Researchers think that some women may be naturally more likely to develop lymphoedema, whatever surgery they had. The aim of this study is to look into this and the possible reasons for it. They are recruiting women who are going to have surgery to remove lymph glands from the armpit, and women who had their surgery more than 3 years ago.
They will look for differences between the women who go on to develop lymphoedema and those who do not. Researchers hope to improve how this condition is managed in future, especially by introducing measures to prevent or limit swelling at an earlier stage. You will not have any direct benefit from taking part in this study and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people with cancer in the future.
Who can enter
If you are suitable for this study, a member of your breast cancer specialist team will ask if you would like to take part. Being chosen does not mean doctors think you are at particular risk of lymphoedema.
This study is made up of 4 smaller studies. The first 3 studies will follow the women taking part for 3 years. Women taking part in one of these 3 studies will
- Have been recently diagnosed with breast cancer and be due to have surgery to remove some or all of the lymph nodes from the armpit on the affected side
- Be between 18 and 77 years old
You cannot enter this study if you
- Have had breast cancer before, unless this was a very early type of breast cancer called ductal carcinoma in situ
- Have had lymphoedema before
- Have had radiotherapy or surgery to your breast or armpit before
- Have serious heart problems
- Have any other condition that would make you unwell if you took part, or affect the results of the study – you can check this with your doctor or with the research team
The 4th study (called study 4a) is running at Guy’s Hospital in London. It is for women who had breast cancer treatment more than 3 years ago, and only for women having follow up appointments at hospitals in South East London.
This study will recruit 136 women altogether. Studies 1, 2, and 3 are for women who have not yet had their surgery.
Everyone taking part in studies 1, 2 and 3 will see the study team both before and after breast surgery. Whether you are in study 1, 2, 3 or 4a, at the start of each visit, the researcher will measure the size of your arms, using a machine called a perometer. This is painless, and measures your arms using light beams.
Study 1 measures the rate of lymph drainage in the muscle in both arms. After the perometer reading, you have an injection of a tiny amount of radioactive ‘tracer’ injected into both arms. You then have gamma camera photos taken of each arm and armpit every 15 to 30 minutes for 3 hours. This records the amount of radioactivity left in each arm, and the lymph drainage is worked out from this.
Study 2 is measuring the rate at which lymph fluid forms in your arms. After the perometer reading, a gentle pressure is applied to both arms using a blood pressure cuff. This makes the veins fill up and encourages fluid to form. The pressure is increased in steps and the very slight expansion of the arm is measured. The cuff is not tight and the pressure applied is much lower than that used by your GP to take your blood pressure.
Study 3 is looking at the pumping function of the tubes that carry lymph (lymphatic vessels), to see whether their weakness comes before the swelling or the surgery. After your perometer reading, you have a blood pressure cuff inflated on the arm on the same side as your cancer. You have a radioactive tracer injection, and gamma camera pictures taken of this arm in the same way as for Study 1. The cuff will be deflated every 15 to 30 minutes, as you have the photos taken. The cuff is not tight and the pressure applied is much lower than that used by your GP to take your blood pressure.
Whether you are in study 1, 2 or 3, at the end of the first visit the team will also measure pressure in the veins in each arm. They will put a small needle called a butterfly into a vein in each arm, and connect this to a pressure recording device. This procedure will only take a few minutes. The butterfly needle is then removed and you can go home.
The team would also like to see you once a year until 3 years after your surgery, to check your arms.
Study 4a involves one half-day visit only. This study is looking at the possible connections between the tubes (vessels) that carry lymph fluid, and blood vessels. Researchers believe that having these connections may protect against lymphoedema in some women, or help it to be less severe. After the perometer reading, you have a thin plastic tube (cannula) put into a vein in each of your arms. They will take a blood sample at the start of your visit, so that a radioactive tracer can be attached to the red blood cells in the sample. The research doctor will then inject this treated blood into the hand on the same side as your cancer. You then give a series of blood samples over 3 hours. You also have gamma camera pictures taken each time. The total amount of blood taken will be less than a tea cup full, which your body can replace easily.
The pressure in your veins will be measured by connecting one of the tubes in your veins to the pressure recording device described above.
For studies 1, 2 and 3 everyone will visit the hospital
- Before their breast surgery
- As soon as you feel well enough after leaving hospital
These visits will take half a day each. You will also visit the hospital once a year until 3 years after your surgery, so the team can check your arms. These visits will be much shorter.
Women taking part in Study 4a will just have the study tests once, at one hospital visit.
Whether you join studies 1, 2, 3 or 4a depends on which hospital you live nearest to.
Study 1 is taking place at Guy’s Hospital in London and Royal Sussex County Hospital in Brighton.
Studies 2 and 3 are taking place at St George’s Hospital in London.
If you had surgery more than 3 years ago, you will only be able to join Study 4a, which is taking place at Guy's Hospital in London.
The team will refund your travel expenses.
There is a risk that putting a needle into the arm after breast cancer treatment (to inject something, or take blood) can cause infection (cellulitis), or even lymphoedema. But as the skin is cleaned carefully and any substance injected is sterile, the team think that any risk of infection is very small. The team will give you antibiotics to reduce this risk further.
You may have a bruise if you have the vein pressure measurement with the butterfly needle.
If you take part in Study 1, you will receive a small amount of radiation from the radioactive injections. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The amount of radiation you would have altogether from the injections for 2 visits is the same as 5 weeks of background radiation.
Study 2 When health professionals take your blood pressure after you have had breast cancer surgery, they use the arm on the unaffected side. Although the team take pressure readings from both arms for this study, the pressures they use are less than your own normal blood pressure. And much lower than the pressure applied to your unaffected arm when your blood pressure is taken normally.
Study 3 The total dose of radiation from the radioactive tracer for two visits to the hospital is similar to 2 weeks of background radiation. Any possible risk from the blood pressure cuff is the same as for Study 2.
Study 4a The total dose of radiation from the radioactive tracer for two visits to the hospital is similar to 3 weeks of background radiation.
Although great care is taken in putting the tubes into your arms, the team will give you a short course of antibiotics to take afterwards, to prevent any infection.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor PS Mortimer
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
St George's Healthcare NHS Trust