Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT

S Mestre, C Calais, G Gaillard, M Nou, M Pasqualini, C Ben Amor, I Quere, S Mestre, C Calais, G Gaillard, M Nou, M Pasqualini, C Ben Amor, I Quere

Abstract

Purpose: Breast cancer-related lymphedema (BCRL) is a debilitating condition. The recommended treatment is based on decongestive lymphedema therapy (DLT) with two separate phases: a short-term intensive phase to reduce lymphedema volume and a long-term maintenance phase to stabilize it. Optimizing compression therapy and compliance during maintenance phase are key factors for long-term control of lymphedema. The primary objective of this pilot prospective open-label randomized study was to assess the benefit of a new auto-adjustable nighttime arm sleeve (MOBIDERM® Autofit) on lymphedema volume during the maintenance phase after the intensive phase.

Methods: Forty women with BRCL were consecutively enrolled and randomized (D0) for 1 month in 1:1 ratio either in night-use group: with MOBIDERM® Autofit (on top of a daytime compression hosiery), or in no night-use group: without MOBIDERM® Autofit (daytime hosiery alone). From Day 31 to Day 90, all patients were fitted with MOBIDERM® Autofit. Primary endpoint was lymphedema volume variation between Day 0 and Day 30. Secondary endpoints were compliance, quality of life (LYMQOL arm questionnaire), functional symptoms (heaviness, limb use limitation, pain), sleep quality, and safety.

Results: In ITT population, between Day 0 and Day 30, mean lymphedema volume increase was higher in no night-use group with 92.9 mL (i.e., 3.2%) than in night-use group with 46.7 mL (i.e., 1.80%), p = 0.757. Between Day 30 and Day 90, all patients fitted with MOBIDERM® Autofit, lymphedema volume remained stable in both groups. The device improved functional symptoms and function domain of the LYMQOL arm questionnaire. MOBIDERM® Autofit was worn overnight almost 85% of the nights. It was well accepted by the patients and no adverse reaction leading to permanent device discontinuation occurred.

Conclusions: Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient's self-management.

Keywords: Breast cancer; Compression; Lymphedema; Maintenance; Self-management; Volume.

Conflict of interest statement

Role of funding source

The sponsor participated in the design of the study, had oversight on the conduct of the study, and participated in interpretation of data and the decision to publish the results. The corresponding author had full access to all of the data and the final responsibility to submit for publication.

Conflict of interest

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Auto-adjustable MOBIDERM® Autofit
Fig. 2
Fig. 2
Disposition of patients in the study
Fig. 3
Fig. 3
Volume excess variation–ITT set. The figure displays the mean volume excess variations (mL) calculated using with circumferential method in the two treatment groups at each time point (Day 30 and Day 90) compared to Day 0 (baseline) and to the initiation of intensive phase (DLT initiation)
Fig. 4
Fig. 4
Functional symptoms evolution legend: the figure shows the evolution of functional symptoms (namely, heaviness and/or pain, and limb use limitation) at each study time points (Day 0, Day 30 and Day 90) in both treatment groups

References

    1. Petrek JA, Heelan MC. Incidence of breast carcinoma-related lymphedema. Cancer. 1998;83:2776–1781. doi: 10.1002/(SICI)1097-0142(19981215)83:12B+<2776::AID-CNCR25>;2-V.
    1. Meric F, Buchholz TA, Mirza NQ, Vlastos G, Ames FC, Ross MI, et al. Long-term complications associated with breast-conservation surgery and radiotherapy. Ann Surg Oncol. 2002;9(6):543–549. doi: 10.1007/BF02573889.
    1. Clark B, Sitzia J, Harlow W. Incidence and risk of arm oedema following treatment for breast cancer: a three-year follow-up study. QJM. 2005;98(5):343–348. doi: 10.1093/qjmed/hci053.
    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. Cheville AL, McGarvey CL, Petrek JA, Russo SA, Taylor ME, Thiadens SR. Lymphedema management. Semin Radiat Oncol. 2003;13(3):290–301. doi: 10.1016/S1053-4296(03)00035-3.
    1. Lymphoedema Framework. Best practice for the management of lymphoedema–International Consensus, 2006. Available at:
    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. Quéré I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, et al. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014;39(4):256–263. doi: 10.1016/j.jmv.2014.05.004.
    1. The International Lymphoedema Framework. Best Practice for the management of lymphoedema - Second edition, 2012.
    1. Haute Autorité de Santé 2010. Dispositifs de compression médicale à usage individuel. Utilisation en pathologies vasculaires. Available at:
    1. Damstra RJ, Partsch H. Compression therapy in breast cancer-related lymphedema: A randomized, controlled comparative study of relation between volume and interface pressure changes. J Vasc Surg. 2009;49(5):1256–1263. doi: 10.1016/j.jvs.2008.12.018.
    1. Megens AM, Harris SR, Kim-Sing C, McKenzie DC. Measurementof upper extremity volume in women after axillary dissectionfor breast cancer. Arch Phys Med Rehabil. 2001;82:1639–1644. doi: 10.1053/apmr.2001.26822.
    1. Galland C, Auvert JF, Flahault A, Vayssairat M. Why and how post-mastectomy edema should be quantified in patients withbreast cancer. Breast Cancer Res Treat. 2002;75:87–89. doi: 10.1023/A:1016522319282.
    1. Keeley V, Crooks S, Locke J, Veigas D, Riches K, Hilliam R. A quality of life measure for limb lymphoedema (LYMQOL) Journal of Lymphoedema. 2010;5(1):26–37.
    1. Boris M, Weindorf S, Lasinkski S. Persistence of lymphedema reduction after noninvasive complex lymphedema therapy. Oncology (Williston Park) 1997;11(1):99–109.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj