Advertisement

Endermology treatment for breast cancer related lymphedema (ELOCS): Protocol for a phase II randomized controlled trial

      Abstract

      Objectives

      Secondary lymphedema is a serious and debilitating condition, which may cause a range of cutaneous, infectious and joint complications with major psychological and social consequences. There is no curative treatment available. Initial symptomatic treatment includes Intensive Decongestive Treatment (IDT), which involves the use of multi-layered compression bandages, along with manual lymph drainage, physical exercise and skin care. IDT leads to an average decrease in limb volume of 20–40%, when compared to the contralateral limb. A better reduction may be obtained through the use of new adjuvant techniques, of which endermology is an example. The aim of this phase II study is to validate an IDT protocol combining endermology with standard of care in breast cancer related lymphedema.

      Study design

      A standardised care protocol was proposed by the University Hospital of Toulouse’s Lymphology team for the treatment of upper limb lymphedema after breast cancer surgery using Cellu M6 (LPG) Endermologie over 30 min. Every patient benefitted from IDT over 5 consecutive days, within the multidisciplinary Lymphology unit. Patients were randomised into three arms as follows: Arm 1: IDT for 5 days with bandages + manual lymphatic drainage. Arm 2: IDT with bandages + manual lymphatic drainage + Cellu M6 for 5 days. Arm 3: bandages + Cellu M6 for 5 days. During the study, patients will be followed-up for a period of 6 months.
      Use of LPG’s Cellu M6 in combination with IDT may improve upper limb volume reduction compared with standard of care. By improving breast cancer related lymphedema, we expect to minimise further fluid build-up and to improve skin care, thus reducing the number of consultations and hospital admissions caused by this condition. The results of the present research protocol are expected to promote evidence supporting the use of endermology in the field of lymphology.

      Abbreviations:

      EV (Excess volume), VL (Volumes limb), VH (Healthy limb), EVD (Excess volume on day), ISL (International society of lymphology), IDT (Intensive decongestive treatment)

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      References

        • Vignes S.
        • Porcher R.
        • Arrault M.
        • Dupuy A.
        Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy.
        Breast Cancer Res Treat. 2007; 101: 285-290
        • Vignes S.
        Lymphedema: From diagnosis to treatment.
        Rev Med Interne. 2017; 38: 97-105
        • National Cancer Institute
        Lymphedema (PDQ) health professional version.
        (Available from URL: http://www.cancer.gov/about-cancer/treatment/side-effects/lymphedema/lymphedema-hp-pdq. [accessed 6/27/16])2019
        • Greenlee H.
        • DuPont-Reyes M.J.
        • Balneaves L.G.
        • Carlson L.E.
        • Cohen M.R.
        • Deng G.
        • et al.
        Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment.
        CA Cancer J Clin. 2017; 67 (06): 194-232
        • International Society of Lymphology
        The diagnosis and treatment of peripheral lymphedema. 2009 Concensus Document of the International Society of Lymphology.
        Lymphology. 2009; 42: 51-60
        • Dupuy A.
        • Benchikhi H.
        • Roujeau J.C.
        • Bernard P.
        • Vaillant L.
        • Chosidow O.
        • et al.
        Risk factors for erysipelas of the leg (cellulitis): case-control study.
        BMJ. 1999; 12 (318): 1591-1594
        • Rodrick J.R.
        • Poage E.
        • Wanchai A.
        • Stewart B.R.
        • Cormier J.N.
        • Armer J.M.
        Complementary, alternative, and other noncomplete decongestive therapy treatment methods in the management of lymphedema: a systematic search and review.
        PM R. 2014; 6 (quiz 274): 250-274
        • Marques M.-A.
        • Combes M.
        • Roussel B.
        • Vidal-Dupont L.
        • Thalamas C.
        • et al.
        Impact of a mechanical massage on gene expression profile and lipid mobilization in female gluteofemoral adipose tissue.
        Obes Facts. 2011; 4: 121-129
        • Bourgeois J.F.
        • Gourgou S.
        • Kramar A.
        • Lagarde J.M.
        • Guillot B.
        A randomized, prospective study using the LPG technique in treating radiation-induced skin fibrosis: clinical and profilometric analysis.
        Skin Res Technol. 2008; 14: 71-76
        • Lhoest F.
        • Grandjean F.-X.
        • Heymans O.
        [Mondor’s disease: a complication after breast surgery].
        Ann Chir Plast Esthet. 2005; 50: 197-201
        • Moseley A.L.
        • Esplin M.
        • Piller N.B.
        • Douglass J.
        Endermologie (with and without compression bandaging)-a new treatment option for secondary arm lymphedema.
        Lymphology. 2007; 40: 129-137
        • Campisi C.
        • Boccardo F.
        • Zilli A.
        • Maccio A.
        • Napoli F.
        • et al.
        [Lymphedema secondary to breast cancer treatment: possibility of diagnostic and therapeutic prevention].
        Ann Ital Chir. 2002; 73: 493-498
        • Moseley Amanda
        • Piller Neil
        • Douglass Jan
        • Esplin Mariélle
        Comparison of the effectiveness of MLD and LPG technique.
        Wounds Int J. 2007; 2
        • Moher D.
        • Schulz K.F.
        • Altman D.
        • Consort Group
        The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001.
        Explore (NY). 2005; 1: 40-45
        • Lennihan R.
        • Mackereth M.
        Calculating volume changes in a swollen extremity from surface measurements.
        Am J Surg. 1973; 126: 649-652
        • Sitzia J.
        Volume measurement in lymphoedema treatment: examination of formulae.
        Eur J Cancer Care (Engl). 1995; 4: 11-16
        • Megens A.M.
        • Harris S.R.
        • Kim-Sing C.
        • McKenzie D.C.
        Measurement of upper extremity volume in women after axillary dissection for breast cancer.
        Arch Phys Med Rehabil. 2001; 82: 1639-1644
        • Galland C.
        • Auvert J.F.
        • Flahault A.
        • Vayssairat M.
        Why and how post-mastectomy edema should be quantified in patients with breast cancer.
        Breast Cancer Res Treat. 2002; 75: 87-89
        • International Society of Lymphology
        The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology.
        Lymphology. 2003; 36: 84-91
        • Fiaschi E.
        • Francesconi G.
        • Fiumicelli S.
        • Nicolini A.
        • Camici M.
        Manual lymphatic drainage for chronic post-mastectomy lymphoedema treatment.
        Panminerva Med. 1998; 40: 48-50
        • Fleming T.R.
        One-sample multiple testing procedure for phase II clinical trials.
        Biometrics. 1982; 38: 143-151
        • Machin David
        • Campbell Michael J.
        • Julious Steven A.
        • Tan Say-Beng
        • Tan Sze-Huey
        Sample size tables for clinical studies.
        third edition. Wiley Blackwell, 2008
        • Yamamoto T.
        • Todo Y.
        • Kaneuchi M.
        • Handa Y.
        • Watanabe K.
        • Yamamoto R.
        Study of edema reduction patterns during the treatment phase of complex decongestive physiotherapy for extremity lymphedema.
        Lymphology. 2008; 41: 80-86
        • 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: 500-515
        • Ahmed R.L.
        • Prizment A.
        • Lazovich D.
        • Schmitz K.H.
        • Folsom A.R.
        Lymphedema and quality of life in breast cancer survivors: the Iowa Women’s Health Study.
        J Clin Oncol. 2008; 26: 5689-5696
        • McWayne J.
        • Heiney S.P.
        Psychologic and social sequelae of secondary lymphedema: a review.
        Cancer. 2005; 104: 457-466
        • Dawes D.J.
        • Meterissian S.
        • Goldberg M.
        • Mayo N.E.
        Impact of lymphoedema on arm function and health-related quality of life in women following breast cancer surgery.
        J Rehabil Med. 2008; 40: 651-658