Is there a constitutional 'global' lymphatic disturbance in lymphatic function in patients who develop breast cancer-related lymphoedema (BCRL)?

Plain English summary of protocol

Background and study aims
Breast-cancer related lymphoedema is a chronic swelling of the upper limb following surgery to the armpit (axilla) lymph nodes and affects about 1 in 4 women having this type of surgery. Lymphoedema is a late complication of the cancer treatment - this means that it usually develops a few years after treatment. Most (but not quite all) cases of lymphoedema occur within 3 years of surgery. We are trying to understand in what way the drainage of tissue fluid from the arm goes wrong in lymphoedema and why some women get it and others do not, even though they have had the same treatment. Tissue fluid is produced constantly and comes from the very small blood vessels (capillaries) found throughout the body. At the same time as it is formed the fluid is drained away by the lymphatic system so that the amount of fluid in the tissues is held roughly constant. When the tissue fluid cannot drain away quickly enough it builds up and the tissue (in this case the tissues in the arm) swell. We know that the root cause of the lymphoedema is the surgical removal of lymph glands in the armpit region (axilla) but we don't understand why some women develop lymphoedema and others do not. Unexpected research findings from our group have led us to think that some women may be more likely to develop lymphoedema regardless of the type of surgery received, and the purpose of this study is to investigate this. If there is an pre-existing or constitutional lymphatic disturbance, then it should be possible to predict those patients who are at risk before they have the surgery. In order to test this, we intend to investigate women who have already had armpit surgery several years previously and investigate the legs rather than the arms. We will adopt this approach because once the swelling has developed, it is not possible to investigate the arms. A constitutional problem with lymphatic drainage should however also affect the legs.

Who can participate?
Potential patients will be identified by liaising with breast care nurse specialists and lymphoedema nurses. The study requires patients who have had surgery for breast cancer at least 3 years ago, and had surgery to their axilla (armpit) to remove lymph nodes.

What does the study involve?
The patients will be approached and the study will be discussed. A patient information sheet will be given to the patient. The patient will be given a minimum of 24 hours to consider participating in the study. A telephone call will be made to determine whether the patient is willing and to answer any questions. Written informed consent will be obtained by either the researchers or research nurse when the patient attends the study visit. The study involves one visit to Royal Sussex County Hospital, Brighton, or Guy’s Hospital, London, lasting about half a day. Lymphoscintigraphy is performed, which is a scan involving the injection of a small quantity of a radioactive substance called technetium-99m nanocolloid. The injection is made into the skin of the webspace between the big toe and 2nd toe (the 1st webspace) of each foot - it is briefly painful and may sting a little. The amount of liquid injected is very small, 1/10th of a millilitre (ml), and a very fine needle is used (it has an outer diameter of 0.2 mm). Most people find it tolerable, and bruising is unlikely. The patients then lie down so that a machine called a gamma camera can be used to take pictures of the legs.

What are the possible benefits and risks of participating?
There is a theoretical risk that any injection can cause infection but this is highly unlikely. The procedures will be performed carefully with cleaning of the skin beforehand. The exposure to radiation from the technetium is very low and would, for example, be equivalent to the exposure to the background level of radiation in the environment over a period of 2 weeks in Sussex (or only half a week in Cornwall, where background radiation is higher than anywhere else in England).

Where is the study run from?
Royal Sussex County Hospital (UK).

When is the study starting and how long is it expected to run for?
The study ran from November 2011 to December 2013.

Who is funding the study?
Brighton & Sussex University Hospitals NHS Trust Cancer Fund.

Who is the main contact?
Prof. A.M. Peters
A.M.Peters@bsms.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs