Treatment of breast cancer-associated lymphedema. A randomized study of the (cost-)effectiveness of manual lymphatic drainage and/or intermittent pneumatic compression

In the Netherlands breast cancer is diagnosed in approximately 11500 women
every year. The life-time probability of developing breast cancer is 9-10%. In
the Netherlands it is the most common cancer in females.1 Lymphedema is the
most frequent complication after the treatment for breast cancer. Recent
studies show an incidence of 20,7% following surgical treatment for breast
cancer.6 Persons with lymphedema suffer from a severe morbidity, and loss of
quality of life. In the Netherlands lymphedema is an underestimated problem.
Most medical doctors hardly recognize the disease, and are not familiar with or
unaware of the
different therapeutic options.

Objective of the study is to evaluate the different therapeutic options of
lymphedema. Which treatment strategy is most cost-effective in the management
of patients with breast cancer associated lymph edema: manual lymphatic
drainage alone, intermittent pneumatic compression alone, or a combination of
both therapies in one treatment program? The results of this will support the
standardisation of the treatment of lymphedema.

This is a randomized controlled study.

Manual lymphatic drainage (MLD) is performed 3 times a week during 30 minutes,
completed by multilayered compression bandages. It is performed by certified
edema therapists, according to the Dr. Vodder-method. Through the pumping
and stretching effect on the lymph vessels, the Dr. Vodder method of MLD
stimulates the contraction of lymph vessels, helping to move the lymph forward
and drain the connective tissue.

Intermittent pneumatic compression (IPC) is performed with a six or
twelve-chamber circular manchet, which is placed around the arm. It is filled
by means of a pneumatic pump with air, with a maximal inflating pressure of 60
mmHg (normal
maximal pressure in lymphedema), during two hours. They inflate from distal to
proximal, thereby producing a wave of pressure that ascends the extremity. The
edema is replaced proximally via the interstitium. It needs to be completed
with multilayered compression bandages to prevent the edema coming back.

After obtaining written consent, patients are randomized to one of three
treatment groups. In group I, patients will receive MLD performed by an edema
therapist, completed with compressive multilayered bandages, three times a
week. In group II, patients are treated with IPC at the department of
dermatology, completed with compressive multilayered bandages, three times a
week. In group III, patients are treated with the combination of subsequently
MLD, performed by an edema therapist, and IPC, completed with compressive
multilayered bandages, three times a week.

After each treatment session its effect will be evaluated by measuring the
circumference of the arm at defined localizations on the arm. In the three
groups the treatment will be ended if in three subsequent treatment sessions no
further volume reduction of the affected arm can be accomplished anymore. Then
a class II therapeutic elastic garment will be measured.

Not applicable.