Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial

Mette Tambour, Marianne Holt, Anette Speyer, Robin Christensen, Bibi Gram, Mette Tambour, Marianne Holt, Anette Speyer, Robin Christensen, Bibi Gram

Abstract

Background: We investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer.

Methods: Patients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T-MLD) received treatment 2×weekly for 4 weeks. The primary outcome was the volume reduction (%) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status.

Results: Despite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T-MLD) completed the trial. In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0% [95% CI, -4.3;2.3%]): the precision in the 95% confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were -6.8%(1.2) and -5.7% (1.2) in the T+MLD and T-MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis.

Conclusion: Manual lymphatic drainage adds no further volume reduction in breast cancer patients.

Trial registration: ClinicalTrials.gov NCT02015897.

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study ‘Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial
Fig. 2
Fig. 2
The primary outcome, lymphoedema volume, after 1 month and after 7 months

References

    1. International WCRF. Breast cancer statistics 2018 [January 2018]. Available from: .
    1. Sundhedsdatastyrelsen. Sundhedsdatastyrelsen. Tabel over nye kræftilfælde. 2018 [cited 2018]. Available from: .
    1. Zou Li, Liu Feng-hua, Shen Pei-pei, Hu Yan, Liu Xiao-qian, Xu Ying-ying, Pen Qi-liang, Wang Bei, Zhu Ya-qun, Tian Ye. The incidence and risk factors of related lymphedema for breast cancer survivors post-operation: a 2-year follow-up prospective cohort study. Breast Cancer. 2018;25(3):309–314. doi: 10.1007/s12282-018-0830-3.
    1. Sarah, A. & Mclaughlin, M. D. Lymphedema: separating fact from fiction (2012). Available from: .
    1. Ribeiro Pereira ACP, Koifman RJ, Bergmann A. Incidence and risk factors of lymphedema after breast cancer treatment: 10 years of follow-up. Breast. 2017;36:67–73. doi: 10.1016/j.breast.2017.09.006.
    1. Moffatt CJ, et al. A preliminary randomized controlled study to determine the application frequency of a new lymphoedema bandaging system. Br. J. Dermatol. 2012;166:624–32. doi: 10.1111/j.1365-2133.2011.10731.x.
    1. Földi, M. & Strößenreuther, R. in Foundations of Manual Lymph Drainage 3rd edn (eds Földi, M. & Strößenreuther, R.) Ch. 7 (Mosby, Saint Louis, 2005).
    1. Földi, M. & Strößenreuther, R. in Foundations of Manual Lymph Drainage 3rd edn (eds Földi, M. & Strößenreuther, R.) Ch. 8 (Mosby, Saint Louis, 2005).
    1. Földi, M. & Strößenreuther, R. in Foundations of Manual Lymph Drainage 3rd edn (eds Földi, M. & Strößenreuther, R.) Ch. 6 (Mosby, Saint Louis, 2005).
    1. Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39:399–405. doi: 10.1080/028418600750013186.
    1. Gradalski T, Ochalek K, Kurpiewska J. Complex decongestive lymphatic therapy with or without Vodder II manual lymph drainage in more severe chronic postmastectomy upper limb lymphedema: a randomized noninferiority prospective study. J. Pain Symptom Manage. 2015;50:750–7. doi: 10.1016/j.jpainsymman.2015.06.017.
    1. Huang TW, et al. Effects of manual lymphatic drainage on breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. World J. Surg. Oncol. 2013;11:15. doi: 10.1186/1477-7819-11-15.
    1. Ezzo, J. et al. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst. Rev. 2015:CD003475.
    1. Lymphoedema Framework. Best Practice for the Management of Lymphoedema. International Consensus (MEP Ltd, London, 2006). Available from: .
    1. Tambour M, Tange B, Christensen R, Gram B. Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial. BMC Cancer. 2014;14:239. doi: 10.1186/1471-2407-14-239.
    1. Kettle JH, Rundle FF, Oddie TH. Measurement of upper limb volumes: a clinical method. Aust. NZ J. Surg. 1958;27:263–70.
    1. Damstra RJ, Glazenburg EJ, Hop WC. Validation of the inverse water volumetry method: a new gold standard for arm volume measurements. Breast Cancer Res. Treat. 2006;99:267–73. doi: 10.1007/s10549-006-9213-0.
    1. Gudex, CT., Thygesen, V., Vestergaard, M. & Jespersen, B. [Validation of the Danish Eq-SD]. Hillerød, Denmark: Psychiatric Reserach Unit, Frederiksborg General;1999).
    1. Sorensen J, Davidsen M, Gudex C, Pedersen KM, Bronnum-Hansen H. Danish EQ-5D population norms. Scand. J. Public Health. 2009;37:467–74. doi: 10.1177/1403494809105286.
    1. McNeely ML, et al. The addition of manual lymph drainage to compression therapy for breast cancer related lymphedema: a randomized controlled trial. Breast Cancer Res. Treat. 2004;86:95–106. doi: 10.1023/B:BREA.0000032978.67677.9f.
    1. Dayes IS, et al. Randomized trial of decongestive lymphatic therapy for the treatment of lymphedema in women with breast cancer. J. Clin. Oncol. 2013;31:3758–63. doi: 10.1200/JCO.2012.45.7192.
    1. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36–9. doi: 10.1136/bmj.313.7048.36.
    1. Brorson H, Hoijer P. Standardised measurements used to order compression garments can be used to calculate arm volumes to evaluate lymphoedema treatment. J. Plast. Surg. Hand Surg. 2012;46:410–5. doi: 10.3109/2000656X.2012.714785.
    1. Földi MFE. Földi's Textbook of Lymphology. San Francisco: Urban &Fisher; 2006.
    1. Kasseroller RG. The Vodder school: the Vodder method. Cancer. 1998;83(12 Suppl American):2840–2. doi: 10.1002/(SICI)1097-0142(19981215)83:12B+<2840::AID-CNCR37>;2-5.
    1. Johansson K, Lie E, Ekdahl C, Lindfeldt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998;31:56–64.
    1. Bergmann A, et al. Physiotherapy in upper limb lymphedema after breast cancer treatment: a randomized study. Lymphology. 2014;47:82–91.
    1. Devoogdt N, et al. Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial. BMJ. 2011;343:d5326. doi: 10.1136/bmj.d5326.

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