Tessa De Vrieze1, Lore Vos1, Nick Gebruers2, Wiebren A A Tjalma3, Sarah Thomis4, Patrick Neven5, Ines Nevelsteen5, An De Groef6, Liesbeth Vandermeeren7, Jean-Paul Belgrado7, Nele Devoogdt8. 1. KU Leuven - University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium; University of Antwerp, Department of Rehabilitation Sciences and Physiotherapy, MOVANT, Antwerp, Belgium. 2. University of Antwerp, Department of Rehabilitation Sciences and Physiotherapy, MOVANT, Antwerp, Belgium; University of Antwerp & Antwerp University Hospital, Multidisciplinary Oedema Clinic, Antwerp, Belgium. 3. University of Antwerp & Antwerp University Hospital, Multidisciplinary Oedema Clinic, Antwerp, Belgium; University of Antwerp, Department of Medicine, MIPRO, Antwerp, Belgium; Antwerp University Hospital, Multidisciplinary Breast Clinic, Antwerp, Belgium. 4. UZ Leuven - University Hospitals Leuven, Department of Vascular Surgery and Department of Physical Medicine and Rehabilitation, Lymphovenous Centre, Leuven, Belgium. 5. UZ Leuven - University Hospitals Leuven, Multidisciplinary Breast Centre, Leuven, Belgium. 6. KU Leuven - University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium. 7. Saint-Pierre University Hospital, Lymphoedema Clinic & Université Libre de Bruxelles, Lymphology Unit, Brussels, Belgium. 8. KU Leuven - University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium; UZ Leuven - University Hospitals Leuven, Department of Vascular Surgery and Department of Physical Medicine and Rehabilitation, Lymphovenous Centre, Leuven, Belgium. Electronic address: nele.devoogdt@uzleuven.be.
Abstract
OBJECTIVES:Lymphoedema is a dreadful complication following breast cancer therapy. According to the International Society of Lymphology, the consensus treatment for breast cancer-related lymphoedema (BCRL) is the decongestive lymphatic therapy. This is a two-phase treatment and combines different treatment modalities including skin care, manual lymphatic drainage (MLD), compression therapy and exercise. However, the additional effect of MLD is debated since pooled data only demonstrated a limited non-significant additional value. A possible explanation is that in previous studies MLD has been applied blind, without knowledge of patient-specific lymphatic routes of transport. In addition, the MLD hand manoeuvres used by the therapists in previous studies, possibly did not optimally stimulate lymphatic transport. Recently, near-infrared fluorescence imaging has been introduced to visualise the superficial lymphatic network which allows MLD at the most needed location. The aim of the present study is to determine the effectiveness of the fluoroscopy-guided MLD, additional to the other parts of the decongestive lymphatic therapy and compared to the traditional or a placebo MLD, in the treatment of BCRL. STUDY DESIGN: A three-arm double-blinded randomised controlled trial will be conducted in different university hospitals in Belgium. Based on a sample size calculation, 201 participants with chronic BCRL stage 1 or 2 of the arm or hand, with at least 5% difference between both sides (corrected for hand dominance) need to be recruited. All participants receive the standard treatment: skin care, compression therapy and exercises. The intervention group additionally receives fluoroscopy-guided MLD. One control group additionally receives the traditional 'blind' MLD and a second control group receives a placebo MLD. All subjects receive 3 weeks of daily intensive treatments and 6 months of maintenance treatment. Follow-up period is 6 months. The primary outcomes are the reduction in lymphoedema volume of the arm/hand and the change in stagnation of lymph fluid at level of the shoulder/trunk.
RCT Entities:
OBJECTIVES: Lymphoedema is a dreadful complication following breast cancer therapy. According to the International Society of Lymphology, the consensus treatment for breast cancer-related lymphoedema (BCRL) is the decongestive lymphatic therapy. This is a two-phase treatment and combines different treatment modalities including skin care, manual lymphatic drainage (MLD), compression therapy and exercise. However, the additional effect of MLD is debated since pooled data only demonstrated a limited non-significant additional value. A possible explanation is that in previous studies MLD has been applied blind, without knowledge of patient-specific lymphatic routes of transport. In addition, the MLD hand manoeuvres used by the therapists in previous studies, possibly did not optimally stimulate lymphatic transport. Recently, near-infrared fluorescence imaging has been introduced to visualise the superficial lymphatic network which allows MLD at the most needed location. The aim of the present study is to determine the effectiveness of the fluoroscopy-guided MLD, additional to the other parts of the decongestive lymphatic therapy and compared to the traditional or a placebo MLD, in the treatment of BCRL. STUDY DESIGN: A three-arm double-blinded randomised controlled trial will be conducted in different university hospitals in Belgium. Based on a sample size calculation, 201 participants with chronic BCRL stage 1 or 2 of the arm or hand, with at least 5% difference between both sides (corrected for hand dominance) need to be recruited. All participants receive the standard treatment: skin care, compression therapy and exercises. The intervention group additionally receives fluoroscopy-guided MLD. One control group additionally receives the traditional 'blind' MLD and a second control group receives a placebo MLD. All subjects receive 3 weeks of daily intensive treatments and 6 months of maintenance treatment. Follow-up period is 6 months. The primary outcomes are the reduction in lymphoedema volume of the arm/hand and the change in stagnation of lymph fluid at level of the shoulder/trunk.
Authors: Tessa De Vrieze; Nick Gebruers; Ines Nevelsteen; Wiebren A A Tjalma; Sarah Thomis; An De Groef; Lore Dams; Vincent Haenen; Nele Devoogdt Journal: Support Care Cancer Date: 2020-11-24 Impact factor: 3.603