Abstract S5-3: Is Manual Lymph Drainage Applied after Axillary Lymph Node Dissection for Breast Cancer Effective To Prevent Arm Lymphoedema? A Randomised Controlled Trial
Authors: Devoogdt N , Christiaens M-R , Geraerts I , Truijen S , Smeets A , Leunen K , Neven P , Van Kampen M. 
Published: April 2011

Abstract
Background and purpose: Recently, one study has proven that the combination of information about the prevention of lymphoedema, exercise therapy and manual lymph drainage (MLD) was more effective to prevent arm lymphoedema than alone information (Lacomba et al 2010). The preventive effect of MLD on the development of lymphoedema has never been investigated in a peer-reviewed randomised controlled trial (Cheville 2010). This single-blinded randomised controlled trial aimed to compare the effect of a treatment programme consisting of information, exercise therapy and MLD (experimental group) and the same programme without MLD (control group) on the development of breast cancer-related lymphoedema.
Material and methods: We included 160 consecutive operable breast cancer patients scheduled for a unilateral axillary lymph node dissection in our Breast Clinic. All patients were randomised into the experimental group (N=79) and control group (N=81) with a randomisation table. Treatment started five weeks after the axillary surgery on average. Patients were treated during 20 weeks. The experimental group received 29 exercise therapy sessions and 34 MLD sessions and the control group received 28 exercise therapy sessions. The assessors were blinded for the allocation to the groups. Primary endpoint was incidence of arm lymphoedema at 6 and 12 months. Lymphoedema was defined as an increase of 2.0 cm or more at two adjacent points of the pre-surgical value. Secondary outcome parameters were time to develop lymphoedema, lymphoedema volume and quality life at 3, 6 and 12 months post-surgery and functioning problems related to lymphoedema 12 months post-surgery. This study is registered, number NTR1055.
Figure 1. Time to develop lymphoedema after axillary lymph node dissection for breast cancer (weeks post-surgery). A comparison is made between experimental group (solid line) and control group (dashed line) by using Log Rank-test.
Results: Eight patients of the experimental group and five patients of the control group were lost to follow-up. Overall incidence rates for lymphoedema were comparable between both groups both at 6 months (12% vs 10%, odds ratio 1.2 [95% CI 0.4 — 3.4]; p=0.69) and at 12 months (23% vs 18%, odds ratio 1.3 [95% CI 0.6 — 2.9]; p=0.54). Figure 1 shows Kaplan-Meier survival analysis up to 12 months post-surgery. Time to develop lymphoedema was comparable in the experimental and control group (log rank P&gt;0.05). Furthermore, both patient groups had 3, 6 and 12 months after surgery, a similar increase of arm volume compared with the pre-surgical level (P&gt;0.05) and a comparable quality of life (P&gt;0.05). Finally, lymphoedema patients in both groups had comparable functioning problems due to their lymphoedema (P&gt;0.05).
Conclusion: MLD applied after axillary lymph node dissection for breast cancer is not effective to prevent arm lymphoedema at short-term.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr S5-3.