Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial

Margaret L McNeely, Kristin L Campbell, Marc Webster, Urve Kuusk, Karen Tracey, John Mackey, Margaret L McNeely, Kristin L Campbell, Marc Webster, Urve Kuusk, Karen Tracey, John Mackey

Abstract

Background: Lymphedema is a prevalent long-term effect of breast cancer treatment that is associated with reduced quality of life. More recent observational data suggest that the addition of night-time compression to day-time use of a compression garment results in better long-term control of arm lymphedema. The primary objectives of the randomized controlled phase of the trial are to determine the efficacy of night-time compression on arm lymphedema volume maintenance and quality of life in breast cancer survivors who have completed intensive reduction treatment for their lymphedema.

Methods/design: The study will be a parallel 3-arm, multi-centre randomized fast-track trial. A total of 120 women with breast cancer related lymphedema will be recruited from 3 centres in Canada and randomized to group 1: Day-time compression garment alone or Group 2: Day-time compression garment + night-time compression bandaging or Group 3: Day-time compression garment + use of a night-time compression system garment. The duration of the primary intervention period will be 12 weeks. The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design. The primary outcome variables: differences from baseline to week 12 in arm volume and quality of life (Lymphoedema Functioning, Disability and Health Questionnaire: Lymph-ICF). Secondary outcomes include bioimpedance analysis, sleep disturbance and self-efficacy. All measurements are standardized and will be performed prior to randomization, and at weeks 6, 12, 18 and 24.

Discussion: The use of night-time compression as a self-management strategy for chronic breast cancer related lymphedema is seen as an innovative approach to improve long-term control over the condition. This trial aims to advance the knowledge on self-management strategies for lymphedema.

Trial registration: This trial was registered at clinicaltrials.gov on July 9(th), 2014 ( NCT02187289 ).

Keywords: Breast cancer; Compression therapy; Lymphedema; Physical therapy.

Figures

Fig. 1
Fig. 1
Compression bandaging
Fig. 2
Fig. 2
Example of strapped version of a night-time compression system garment
Fig. 3
Fig. 3
Study schema

References

    1. Canadian Cancer Statistics; 2015. . Accessed 1 Oct 2015.
    1. Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg. 1999;177(3):184–188. doi: 10.1016/S0002-9610(99)00008-2.
    1. DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013;14(6):500–515. doi: 10.1016/S1470-2045(13)70076-7.
    1. Paskett ED, Naughton MJ, McCoy TP, Case LD, Abbott JM. The epidemiology of arm and hand swelling in premenopausal breast cancer survivors. Cancer Epidemiol Biomarkers Prev. 2007;16(4):775–782. doi: 10.1158/1055-9965.EPI-06-0168.
    1. Hayes SC, Janda M, Cornish B, Battistutta D, Newman B. Lymphedema after breast cancer: incidence, risk factors, and effect on upper body function. J Clin Oncol. 2008;26(21):3536–3542. doi: 10.1200/JCO.2007.14.4899.
    1. Campbell KL, Pusic AL, Zucker DS, McNeely ML, Binkley JM, Cheville AL, Harwood KJ. A prospective model of care for breast cancer rehabilitation: function. Cancer. 2012;118(8 Suppl):2300–2311. doi: 10.1002/cncr.27464.
    1. Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. J Clin Oncol. 2012;30(30):3726–3733. doi: 10.1200/JCO.2012.41.8574.
    1. Shih YC, Xu Y, Cormier JN, Giordano S, Ridner SH, Buchholz TA, Perkins GH, Elting LS. Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol. 2009;27(12):2007–2014. doi: 10.1200/JCO.2008.18.3517.
    1. Framework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006. London: MEP Ltd; 2006.
    1. Armer JM. Lymphedema. In: Hassey Dow K, editor. Nursing Care of Women with Cancer. St. Louis: Mosby Elsevier; 2006. pp. 204–225.
    1. Chang CJ, Cormier JN. Lymphedema interventions: exercise, surgery, and compression devices. Semin Oncol Nurs. 2013;29(1):28–40. doi: 10.1016/j.soncn.2012.11.005.
    1. Lasinski BB, McKillip Thrift K, Squire D, Austin MK, Smith KM, Wanchai A, Green JM, Stewart BR, Cormier JN, Armer JM. A systematic review of the evidence for complete decongestive therapy in the treatment of lymphedema from 2004 to 2011. PM R. 2012;4(8):580–601. doi: 10.1016/j.pmrj.2012.05.003.
    1. Vignes S, Porcher R, Arrault M, Dupuy A. Factors influencing breast cancer-related lymphedema volume after intensive decongestive physiotherapy. Support Care Cancer. 2011;19(7):935–940. doi: 10.1007/s00520-010-0906-x.
    1. International Society of Lymphology Consensus document of the International Society of Lymphology. Lymphology. 2003;36(2):84–91.
    1. Harris SR, Hugi MR, Olivotto IA, Levine M. Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema. CMAJ. 2001;164(2):191–199.
    1. Stanton AW, Northfield JW, Holroyd B, Mortimer PS, Levick JR. Validation of an optoelectronic limb volumeter (Perometer) Lymphology. 1997;30(2):77–97.
    1. Armer JM, Stewart BR. A comparison of four diagnostic criteria for lymphedema in a post-breast cancer population. Lymphat Res Biol. 2005;3(4):208–217. doi: 10.1089/lrb.2005.3.208.
    1. Ancukiewicz M, Russell TA, Otoole J, Specht M, Singer M, Kelada A, Murphy CD, Pogachar J, Gioioso V, Patel M, et al. Standardized method for quantification of developing lymphedema in patients treated for breast cancer. Int J Radiat Oncol Biol Phys. 2011;79(5):1436–1443. doi: 10.1016/j.ijrobp.2010.01.001.
    1. Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther. 2011;91(6):944–957. doi: 10.2522/ptj.20100087.
    1. Ward LC, Czerniec S, Kilbreath SL. Quantitative bioimpedance spectroscopy for the assessment of lymphoedema. Breast Cancer Res Treat. 2009;117(3):541–547. doi: 10.1007/s10549-008-0258-0.
    1. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study Sleep measure. Sleep Med. 2005;6(1):41–44. doi: 10.1016/j.sleep.2004.07.006.
    1. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256–262.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi