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Vienna, Austria

ESTRO 2023

Session Item

Monday
May 15
10:30 - 11:30
Hall A
Breast
Carlotta Becherini, Italy;
Sandra Demaria, USA
Proffered Papers
Clinical
11:00 - 11:10
Effect of manual lymph drainage in people with breast cancer-related lymphedema: EFforT-BCRL trial
Tessa De Vrieze, Belgium
OC-0767

Abstract

Effect of manual lymph drainage in people with breast cancer-related lymphedema: EFforT-BCRL trial
Authors:

Tessa De Vrieze1,3, Ines Nevelsteen2, Nick Gebruers3, Steffen Fieuws4, Sarah Thomis5, An De Groef1, Wiebren Tjalma6, Jean-Paul Belgrado7, Liesbeth Vandermeeren8, Chris Monten9, Marianne Hanssens10, Nele Devoogdt1

1KU Leuven, Rehabilitation Sciences and Physiotherapy, Leuven, Belgium; 2UZ Leuven, Oncological Surgery, Leuven, Belgium; 3UAntwerpen, Rehabilitation Sciences and Physiotherapy, Antwerpen, Belgium; 4KU Leuven, Statistics, Leuven, Belgium; 5UZ Leuven, Vascular Surgery, Leuven, Belgium; 6Antwerp University Hospital, Multidisciplinary Breast Clinic, Antwerpen, Belgium; 7ULB, Lymphology Unit, Brussels, Belgium; 8Mirha, Lymphedema Clinic, Brussels, Belgium; 9UZ Gent, Radiology, Gent, Belgium; 10AZ Groeninge Hospital, Oncology, Kortrijk, Belgium

Show Affiliations
Purpose or Objective

Importance: Although worldwide applied for the treatment of breast cancer-related lymphedema (BCRL), the effectiveness of manual lymph drainage (MLD) remains unclear. Since 1930, traditional MLD is applied. Recently, the method of MLD has been optimised by making it patient-tailored (i.e. fluoroscopy-guided MLD).

Objective: To investigate the effectiveness of fluoroscopy-guided MLD additional to decongestive lymphatic therapy (DLT), compared to traditional or placebo MLD, for the treatment of BCRL.

Material and Methods

Design: Multicentre, three-arm, double-blinded RCT

Setting: Five hospitals in Belgium

Participants: 194 participants with unilateral chronic BCRL were enrolled. Four patients were lost to follow-up during the intensive treatment phase.

Interventions: Participants were randomised into one of three groups, receiving standard DLT (consisting of education, skin care, compression therapy and exercises) either including fluoroscopy-guided MLD (n=63), traditional MLD (n=63) or placebo MLD (n=64). Participants received 14 sessions of physical therapy during the 3-weeks intensive phase and received 17 sessions during the 6-months maintenance phase. 

Main outcome measures: Primary outcomes were 1) change in excessive volume reduction of the arm/hand, and 2) change in excessive volume accumulation at the shoulder/trunk. Primary endpoint was at the end of the intensive phase. Measurements were performed at baseline, after the intensive phase, after 1, 3, 6 months of maintenance phase, and after 6 months of follow-up.

Results

Results: In all three groups, excessive lymphedema volume decreased significantly after three weeks of intensive treatment (p< 0.001). No differences between the fluoro-MLD group (mean absolute reduction of 5.3 (95% CI: 3.9 -6.7) percentage points of % excessive volume representing a relative reduction of 23.3%) and the traditional MLD group (mean absolute reduction of 5.2 (95%CI 3.8-6.6) percentage points of % excessive volume, which is a relative reduction of 20.9%) (mean difference between groups: 0.0% (95% CI: -2.0; 2.1, p=0.890), or between the fluoro-MLD group and the placebo MLD group (mean absolute reduction (95% CI) or 5.4 (95%CI: 4.0-6.8) percentage points of % excessive volume, or a relative reduction of 24.8%) (mean difference between groups (95% CI): -0.2% (-2.1; 1.8, p=0.826) were found. An increased fluid accumulation at the level of the shoulder/trunk was present in all three treatment groups, however, this was not significantly different between the groups (p>0.0125) (mean difference between the fluoro-MLD and traditional MLD group (95% CI): -3.6% (-6.4; -0.8), p= 0.013; mean difference between fluoro-MLD and placebo-MLD group (95% CI): -2.4% (-5.2; 0.4, p=0.101))

Conclusion

Conclusions: In patients with chronic BCRL, evidence for a benefit of MLD in addition to the other components of DLT could not be demonstrated. There is no indication to still prescribe and include time-consuming MLD in the treatment of BCRL.

NCT02609724, EudraCT 2015-004822-33