The effectiveness of decongestive treatments provided within 12 months of developing a swollen arm for women with breast cancer-related lymphedema: a systematic review protocol of quantitative evidence

Abstract

Review question/objective The objective of this review is to identify the effectiveness of decongestive lymphedema treatment to reduce excess limb volume or improve patient-centered outcomes for women presenting within 12 months of developing a swollen arm due to breast cancer-related lymphedema. More specifically, the objectives are to identify: 1) The most effective combination of treatment elements 2) The optimal duration of treatment. Background Lymphedema is a common sequelae of breast cancer treatment, affecting around 20% of women following axillary node dissection.1 Although lymphedema is more likely to develop within the first 24 months following axillary surgery,1 instances of lymphedema are also reported many years after the original surgery,2,3 for example, it is likely that of the 50,000 cases of breast cancer diagnosed in the UK in 2011,4 around 7000 women will already have developed arm swelling. The physical and psycho-social consequences of breast cancer-related lymphedema (BCRL) affecting the ipsilateral arm and associated quadrant of the trunk are significant and wide ranging: increased size, altered appearance of arm, difficulty finding clothes to fit, heaviness, discomfort or pain in the affected arm,3,5 reduced upper body function,3,6 challenges with work,7-9 social and leisure activities,7,10 psychological distress and altered body image.7,11 Individuals may experience financial impacts regarding treatment, which could include traveling to appointments, time off work, and in some countries a requirement to personally pay for certain aspects of treatment;12 some women may even need to adjust their employment or find alternative work.8 The economic consequences on health service provision are likely to be significant, although there is limited evidence for health resource use. These costs may include provision of specialist and long-term lymphedema treatment, management of poorly controlled symptoms, or supportive social care when appropriate lymphedema treatment is not available.13-15 The internationally accepted gold standard treatment for lymphedema is generally considered to be complex decongestive therapy (CDT), also known as decongestive lymphedema treatment (DLT),16-20 which is a two-phase treatment program. The recommended first phase of treatment is an intensive therapist-led decongestive phase (I), designed to reduce size and extent of swelling, which is followed by a maintenance phase (II) where the patient undertakes daily self-management to retain treatment benefits long-term. A systematic review of the evidence for lymphedema treatment (2004-2010) undertaken by the American Lymphedema Framework Project concluded that there is evidence for the efficacy of CDT to treat varying degrees of lymphedema, whether recent onset or chronic, mild, moderate or severe; however, the level of evidence was only moderately strong due to the limited number of adequately controlled studies, variation in protocols for intervention and measurements, and limited follow-up period.18 A wide range of reported CDT/DLT protocols exist, which combine graduated compression, the usage of bandages or hosiery, manual lymph drainage (MLD), exercise and skin care, and may also include intermittent pneumatic compression (IPC) as an adjunct.16,18,19,21 Phase I decongestive treatment is generally applied five to seven days per week for three to eight weeks to arrest development and reverse the effects of chronic swelling. Reported benefits include reduced limb size, softened skin and subcutaneous tissues, reduction in recurrent infections, and improved quality of life and function.22 It is thought that early application of decongestive treatment in the months immediately following development of BCRL will significantly reduce lymphedema at the time when it is likely to be most responsive to treatment (before tissues changes become established), thus increasing the possibility of long-term successful management of BCRL. However, recent studies have questioned whether traditional CDT is more effective than self-care measures to reduce lymphedema of less than one year duration, although Hwang et al.25 concluded that early application of CDT prevents subsequent deterioration in lymphedema over time.23,24 Lymphedema management does not always follow the internationally recognized two-phase DLT program, largely due to financial challenges and limited availability of trained practitioners, and because hosiery does achieve some lymphedema reduction.26,27,28,29 For example, in Turkey, intensive phase I treatment is not available through the national health service and patients must individually pay for this aspect of treatment. In the UK, most women presenting with mild-moderate BCRL are taught self-care measures and given compression hosiery which represents phase II maintenance treatment, with the intensive decongestive phase reserved for the more severe cases and those who have access to private health care.12,15,19,30 However, women who present with mild swelling are at risk of developing moderate to severe swelling with associated increased healthcare costs, and there is a high risk that self-care measures alone will cause the lymphedema to worsen, resulting in thickened skin and subcutaneous tissues, increasing the complexity of swelling and reducing the effectiveness of treatment.3,17 Despite recent advances in breast cancer treatment, BCRL continues to be a problem for many women. Treatment for BCRL is required life-long and the lymphedema caseload increases year-on-year causing greater pressure on finite health care resources. Early and effective treatment will lessen the impact of BCRL and its treatment for the individual, prevent long-term complications, and reduce the need for long-term specialist treatment. More effective treatment could enable quicker discharge from specialist services, less complex lymphedema could require less expensive compression garments and associated specialist treatments, and the risk of infection and associated costs of treatment could be lowered. With more effective treatment it may be possible for those with mild lymphedema to return to the latent phase, that is, with no visible or palpable lymphedema. In short, the long-term cost of managing BCRL could be lessened by reducing the size and complexity of the lymphedema caseload. This review seeks to establish the best available evidence for treatment to decongest BCRL of the upper limb in women. Although there have been recent systematic reviews addressing individual treatment modalities applied to BCRL,31-35 the most recent systematic review specifically addressing the management of breast cancer-related lymphedema was published in 2010.36 There are gaps in knowledge and further studies have been published in the intervening years. No review has addressed the impact of the duration of lymphedema on treatment outcome. The optimal decongestive lymphedema treatment package is still not known: protocols include variations in the elements of treatment, particularly with respect to whether compression should be applied through bandaging, hosiery, or intermittent pneumatic compression pump. The optimal duration of treatment is unknown, although a recent study,37 reported programs vary in length from two to eight weeks, and recommended that the program should not be shorter than two weeks. The optimal time for the intensive phase of decongestive treatment is unknown, with apparently conflicting evidence from recently published studies.23,24 This systematic review will focus on the evidence for the effectiveness of decongestive lymphedema treatment for the early management of BCRL within 12 months of the development of lymphedema symptoms. The findings will be used to inform effective management of BCRL, particularly for women newly presenting with arm swelling.