A study looking at treating lymphoedema with surgery before having standard treatment (PRELUDE)
Cancer type:
Status:
Phase:
This study is looking into how well surgery works for lymphoedema in comparison to the standard treatment of exercise and bandaging.
It is open to people who have lymphoedema of the arm after breast cancer surgery.
More about this trial
Lymphoedema is a build up of 
. Surgery can affect the drainage channels of the that carries the fluid away. This means that the fluid doesn’t drain in the normal way and the area swells. For breast cancer this usually develops in the arm on the side where the cancer was.
The for lymphoedema is exercises and compression bandages or garments for the arm.
In this study researchers are looking at surgery to change the route of the lymph vessels. The surgeon attaches the lymph vessels to nearby tiny blood vessels (veins). The lymph fluid can then drain into the veins reducing the amount of fluid in the arm. This is lymphaticovenous surgery (LVA).
Researchers think that having LVA before starting standard treatment might be better than standard treatment on its own. In the study you have either:
- standard treatment on its own
- LVA then standard treatment
The aims of this study are to find out:
- how well LVA before standard treatment works
- how safe it is
- how it affects
quality of life
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if you are going to a breast cancer clinic or lymphoedema clinic at the Royal Marsden Hospital (Chelsea and Sutton) and all of the following apply.
- You have lymphoedema after having breast cancer surgery that included removing the lymph nodes from the armpit.
- The lymphoedema has increased the size of the limb by more than 10% for at least a month.
- You have finished additional treatment (
adjuvant ) after surgery apart from hormone therapy. - You developed lymphoedema in the past 6 months.
Who can’t take part
You cannot join this study if any of these apply. You:
- can’t have an injection of a
contrast medium because you are allergic to iodine or have an underactive thyroid (hypothyroidism) - have had lymphoedema before
- have cancer that has spread to another part of the body (metastatic), come back after treatment (recurrent) or is getting worse (progressive)
- might not be able to have the study treatment because there isn’t enough information available from your surgery or the study treatment isn’t suitable for you
- have other conditions such as heart and breathing problems that increase your risk of complications from having a
general anaesthetic
Trial design
The study team need 64 people to take part.
It is a randomised study. There are 2 groups. Neither you nor your doctor chooses which group you are in. The 2 groups are:
- 32 people have standard treatment
- 32 people have LVA surgery then standard treatment
Not everyone can have LVA surgery. People in the LVA surgery group have tests after randomisation to make sure they are suitable.
People who aren’t suitable are referred to a lymphoedema specialist for treatment.
You have the LVA surgery at the Royal Marsden Hospital. You have it under a . You are in hospital for the day. You can go home the same day as your surgery if you are well enough, if not then the morning after.
Photograph
The team take a photo of your arm with lymphoedema. This is to have a visual record of what is happening. You have it when you join the study and then at:
- 3 months
- 6 months
- 1 year
The photo is only of your arm and you won’t be able to be identified from it.
Quality of life
You fill in a questionnaire when you join the study then at:
- 3 months
- 6 months
- 1year
The questions ask about:
- your general health
- how you feel
- your lymphoedema
This is a quality of life questionnaire.
Hospital visits
People in the LVA and standard treatment group
You see the doctor to have tests before taking part.
For people having LVA these tests include:
- assessing the blood vessels in the arm and the lymph channels to find out if you are suitable for LVA
- taking measurements of both arms
- measuring how much water is in your body
- assessing if there is any infection on your arm affected by lymphoedema
After surgery you see the doctor and or nurse at:
- 1 week
- 2 weeks
- 1 month
- 3 months
- 6 months
- 1 year
Your arms and amount of body water are measured again at:
- 1 month
- 3 months
- 6 months
- 1 year
People in the standard treatment group
For those having standard treatment these tests include:
- measuring both arms
- measuring how much water is in your body
- assessing if there is any infection on your arm affected by lymphoedema
You see the doctor and or nurse at:
- 1 month
- 3 months
- 6 months
- 1 year
You have your arms and amount of body water measured at these times.
Side effects
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
There is little evidence to show that having surgery can make lymphoedema worse.
There is a risk that the surgery might not work. And over time your lymphoedema might get worse with or without the surgery. In these cases, your doctor or a specialist lymphoedema therapist can help you manage your lymphoedema.
We have information about lymphoedema after breast cancer treatment.
Your doctor or a member of the study team will talk to you about the possible side effects of the treatments in the study before you agree to take part.
Location
Recruitment start:
Recruitment end:
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.
Chief Investigator
Kelvin Ramsey
Supported by
Institute of Cancer Research (ICR)
Royal Marsden Hospital Charitable Fund
The Royal Marsden Foundation Trust
NIHR Royal Marsden Biomedical Research Centre
Other information
For more information on this study, you can contact Karmina.Claros@rmh.nhs.uk and Ethel.Black@rmh.nhs.uk.
The study team welcome enquires from outside the stated locations on this page.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
