Efficacy of self-administered complex decongestive therapy on breast cancer-related lymphedema: a single-blind randomized controlled trial
After surgery, breast cancer-related lymphedema (BCRL) is a frequent chronic condition. The complex decongestive therapy (CDT) delivered by physiotherapists at hospitals is the state-of-the-art treatment choice. As lymphedema requires continuous management, we designed a 1-month-long course to train women to professionally carry out a self-administered CDT (saCDT) and tested its efficacy while keeping the benefits of CDT.
Consecutive patients treated with CDT over a 1-year period at an Italian facility were randomly assigned to either experimental (EXP, saCDT course) or control (CTRL, usual care) group. Women were assessed before, at 1, and 6 months from enrolment. Pain assessed by the numerical pain rating scale (NPRS) was the primary outcome. Arm asymmetry assessed by the excess limb volume (ELV) was the secondary outcome. Outcome variations were compared to their MCID to classify women as improved, stable, or worsened.
Forty-one women were included. The proportion of stable or improved women was significantly different between EXP and CTRL groups at 6 months after enrolment for both arm pain (p = 0.01) and asymmetry (p < 0.01). Noteworthy, only one EXP woman had worsened after 6 months. NPRS significantly decreased in the EXP group only, with a median variation of 2 points. Arm ELV significantly decreased with respect to the baseline value in the EXP group only, with a median reduction of 8%.
Teaching saCDT to women with BCRL is effective in maintaining or improving the benefits of CDT and can be used as a self-care tool in the management of BCRL.
KeywordsLymphedema Breast cancer Self-care Complex decongestive therapy
The authors would like to acknowledge Dr. Franca Coppadoro and her team at the Fatebenefratelli Hospital, Milan, Italy, for their kind and fruitful suggestions on the use of self-treatment in the management of lymphedema.
MBL, IC, AM: Conceptualization—Ideas; formulation or evolution of overarching research goals and aims. IC, AM: Data Curation—Management activities to annotate (produce metadata), scrub data, and maintain research data (including software code, where it is necessary for interpreting the data itself) for initial use and later reuse. AM: Formal Analysis—Application of statistical, mathematical, computational, or other formal techniques to analyze or synthesize study data. ML: Funding Acquisition—Acquisition of the financial support for the project leading to this publication. IC, AC, PV, MBL: Investigation—Conducting a research and investigation process, specifically performing the experiments, or data/evidence collection. IC: Methodology—Development or design of methodology; creation of models. IC: Project Administration—Management and coordination responsibility for the research activity planning and execution. n.a.: Resources—Provision of study materials, reagents, materials, patients, laboratory samples, animals, instrumentation, computing resources, or other analysis tools. AM: Software—Programming, software development; designing computer programs; implementation of the computer code and supporting algorithms; testing of existing code components. IC: Supervision—Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team. n.a.: Validation—Verification, whether as a part of the activity or separate, of the overall replication/reproducibility of results/experiments and other research outputs. AM, IC: Visualization—Preparation, creation and/or presentation of the published work, specifically visualization/data presentation. AM, IC: Writing—Original Draft Preparation—Creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation). n.a.: Writing—Review & Editing—Preparation, creation, and/or presentation of the published work by those from the original research group, specifically critical review, commentary, or revision—including pre- or post-publication stages.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed during studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and comply to the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was approved by the local Ethics Committee (2017/0123714). All women signed an informed consent to data treatment.
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