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Randomized Controlled Trial
. 2025 Jul;212(1):123-138.
doi: 10.1007/s10549-025-07709-3. Epub 2025 May 6.

Self-administered versus lymphedema therapist-administered complex decongestive therapy protocol in breast cancer-related lymphedema: a non-inferiority randomized controlled trial with three-month follow-up

Sukriye Cansu Gultekin  1 , Didem Karadibak  2 , Ahmet Burak Cakir  3 , Zeynep Gulsum Guc  4 , Tugba Yavuzsen  5
Affiliations
Randomized Controlled Trial

Self-administered versus lymphedema therapist-administered complex decongestive therapy protocol in breast cancer-related lymphedema: a non-inferiority randomized controlled trial with three-month follow-up

Sukriye Cansu Gultekin et al. Breast Cancer Res Treat. 2025 Jul.

Abstract

Purpose: The aim of this study was to demonstrate that a self-administered complex decongestive therapy (CDT) protocol is not inferior to certified lymphedema therapist (CLT)-administered CDT in the management of lymphedema and health-related outcomes in patients with breast cancer-related lymphedema (BCRL).

Methods: Fifty patients with BCRL were randomly assigned to two experimental groups: (1) a CLT-administered CDT group (n = 25) or a self-administered CDT group (n = 25). CDT was a multimodal approach in two experimental conditions consisting of patient education, manual lymph drainage, multi-layer bandaging, therapeutic exercises and skin/nail care. Lymphedema severity was assessed using circumference measurement, and BCRL-related symptoms were assessed using a numerical rating scale. The following measurement methods were used to assess health-related outcomes: universal goniometer for range of motion (ROMs), hand grip dynamometer for peripheral muscle strength, disabilities of the arm, shoulder and hand (DASH) questionnaire for disability level, International Physical Activity Questionnaire-Short Form (IPAQ-SF) for physical activity level, the checklist for individual strength (CIS) for fatigue and upper limb lymphedema quality of life questionnaire (ULL-27) for quality of life.

Results: Following CDT, there was a significant decrease in lymphedema severity and lymphedema-related symptoms in both groups (p < 0.001). There was no significant difference between the groups regarding the mean difference in health-related outcomes following CDT (post-treatment-baseline) (p < 0.05). Lymphedema severity and symptoms remained stable during the 3-month follow-up periods in the CLT-administered CDT group (p > 0.05). There was a decrease in the severity of lymphedema, stiffness, heaviness and fatigue in the self-administered CDT group at 3-month follow-up (p < 0.05), while pain and tingling remained unchanged (p > 0.05).

Conclusion: The present findings demonstrated self-administered CDT protocol is not inferior to CLT-administered CDT in the management of lymphedema and reduction of lymphedema-related disabilities.

Keywords: Breast cancer; Complex decongestive therapy; Health parameters; Self-care; Upper extremity lymphedema.

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Conflict of interest statement

Declarations. Conflict of interest: The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Ethical approval: Ethical approval was obtained from Dokuz Eylul University Non-Invasive Research Ethics Committee (decision number: 2023/34-09, date: 25.10.2023). Consent to participate: Informed consent was obtained from all participants and all procedures were performed in accordance with the Declaration of Helsinki.

Figures

Fig. 1
Fig. 1
Flowchart of the study protocol
Fig. 2
Fig. 2
Change in Lymphedema Severity (cm3) and Lymphedema-Related Symptoms Across Study Time Points. Repeated-measures ANOVA analyses revealed a time-dependent change in lymphedema severity (cm3) and lymphedema-related symptoms in both groups (p < 0.05). Error bars represent standard deviation. Bonferroni correction was applied to p values, with a significance threshold set at p < 0.017. CLT-CDT: Certified lymphedema therapist-administered complex decongestive therapy, Self-CDT Self-administered complex decongestive therapy
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References

    1. Tabár L et al (2019) The incidence of fatal breast cancer measures the increased effectiveness of therapy in women participating in mammography screening. Cancer 1254:515–523. 10.1002/cncr.31840 - PMC - PubMed
    1. Hortobagyi GN (2003) The curability of breast cancer: present and future. Eur J Cancer Suppl 11:24–34. 10.1016/S1359-6349(03)00003-X
    1. McLaughlin SA, Brunelle CL, Taghian A (2020) Breast cancer-related lymphedema: risk factors, screening, management, and the impact of locoregional treatment. J Clin Oncol 3820:2341–2350. 10.1200/JCO.19.02896 - PMC - PubMed
    1. Shih YC et al (2009) Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol 2712:2007–2014. 10.1200/jco.2008.18.3517 - PubMed
    1. (2020) The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology 531: 3-19 - PubMed

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