OBJECTIVE: To evaluate the effect of the addition of manual lymph drainage to a treatment programme comprised of guidelines and exercise therapy for the prevention of arm lymphoedema after axillary dissection for breast cancer. DESIGN: Single-blinded RCT. METHOD: We included 160 breast cancer patients who had undergone a unilateral axillary dissection in the period of October 2007 to February 2009. Immediately following the operation, patients from the intervention group (n = 79) received postoperative guidelines and engaged in exercise therapy and manual lymph drainage for 6 months. The control group-patients (n = 81) received guidelines and underwent exercise therapy only. The arm volume, arm circumference and body weight of all these patients were measured before the axillary dissection and 1, 3, 6 and 12 months after surgery. Their subjective perceptions of arm lymphoedema and health-related quality of life were also recorded. The primary outcome parameter was the incidence of postoperative arm lymphoedema, defined as an arm-volume-difference increase of 200 ml or more between the operated and healthy side, compared with the preoperative difference. This study has been registered in the Netherlands Trial Register (NTR1055). RESULTS: Four patients in the intervention group and 2 patients in the control group were lost to follow-up. Twelve months after axillary dissection, the incidence of arm lymphoedema was comparable between the intervention and control group: 24 versus 19% (odds ratio 1.3; 95% CI 0.6 to 2.9; p = 0.45). The incidence was comparable between both groups at earlier time points as well. CONCLUSION: We could not prove that manual lymph drainage after axillary dissection for breast cancer in addition to guidelines and exercise therapy has any additional short-term effect on the prevention of arm lymphoedema. It is important to inform patients about this.

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