Currently, each breast cancer patient with arm lymphoedema receives manual lymph drainage (MLD) to treat the oedema. Although MLD is applied to treat breast cancer related-lymphoedema (BCRL) for many years, there is still no consensus about its effectiveness. A possible explanation is that MLD is applied in an inefficient way: during MLD, hand manoeuvres are applied on all lymph nodes and lymphatics that may be anatomically present. After axillary dissection and/ or radiotherapy (for the treatment of breast cancer), the lymphatic system is damaged: lymph nodes are removed and often fibrosis of the superficial lymphatic system occurs. As a result, rerouting of the lymphatic drainage occurs. This rerouting is patient-specific. Consequently, it is possible that the traditional MLD needs be abandoned and a tailored approach needs to be established. Lymphofluoroscopy can aid to apply a more efficient MLD. During lymphofluoroscopy, a fluorescent substance is injected subcutaneously in the hand and it visualizes the transport of lymph from the hand up to the axilla and it demonstrates alternative pathways towards other lymph nodes. A second explanation why the traditional method of MLD is not proven to be effective, is that research has shown that MLD with high pressure (vs low pressure) is more effective to improve lymph transport, as well as gliding (vs no gliding). During the new method of MLD (or fluoroscopy-guided MLD), the therapist only performs hand movements on functional lymphatics and lymph nodes. In addition, the hand movements are applied with higher pressure and lymph transport through the lymph collaterals is stimulated by applying strikes across the skin.
The main scientific objective entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, for the treatment of BCRL. Primary end points are change of lymphoedema volume at the level of the hand, arm, shoulder and trunk and change of functioning problems related to the development of lymphoedema. Secondary end points are the improvement of patient's quality of life, the change of the extracellular fluid in the arm and change of lymphatic function. Secondary scientific objectives entail examining the relationship between different variables of lymphoedema at baseline. Therefore, a multi-centre double-blind randomised controlled trial will be conducted.