Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study

NCT07014657 | Completed

• 1 other identifier: Lenfödemüst2025
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the short- and long-term effects of digital combined decongestive therapy in breast cancer-related lymphedema. Limb volume and quality of life (Lymph-ICF) were assessed at baseline, post-treatment, and 12-week follow-up.

Conditions

Breast Cancer-Related Lymphedema

Keywords

Breast cancer-related lymphedema; Combined decongestive therapy; Digital therapy

Outcome Measures

Primary Outcomes (1)

• Change in Limb Volume

  Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.

  At baseline, at week 4 (end of treatment), and at week 12 (follow-up)

Secondary Outcomes (1)

• Change in Quality of Life

  At baseline, at week 4 (end of treatment), and at week 12 (follow-up)

Study Arms (1)

Digital Combined Decongestive Therapy Group

EXPERIMENTAL

Participants received digital combined decongestive therapy including self-bandaging, self-manual lymphatic drainage, decongestive and breathing exercises, supervised remotely through telecommunication technologies for 4 weeks, followed by maintenance therapy with compression stockings.

Behavioral: Digital Combined Decongestive Therapy

Interventions

Digital Combined Decongestive Therapy BEHAVIORAL

Participants received digital combined decongestive therapy, which included an initial face-to-face session where skin care and risk reduction training were provided. Self-bandaging and self-manual lymphatic drainage techniques were demonstrated and practiced under supervision. Additionally, decongestive and breathing exercises were taught to both patients and caregivers. Following this, the intensive treatment phase was conducted remotely using electronic communication technologies over a period of 4 weeks to monitor and guide the therapy. After the intensive phase, participants continued with maintenance therapy, which involved the use of compression stockings. The therapy aimed to reduce limb volume and improve symptoms related to breast cancer-related lymphedema.

Digital Combined Decongestive Therapy Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with breast cancer-related lymphedema (BCRL) within the last 6 to 60 months.
• Voluntarily agreed to participate in the study.

You may not qualify if:

• Presence of active infection.
• History of bilateral breast surgery.
• Severe breast cancer-related lymphedema.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Borman P, Yaman A, Yasrebi S, Pinar Inanli A, Arikan Donmez A. Combined Complete Decongestive Therapy Reduces Volume and Improves Quality of Life and Functional Status in Patients With Breast Cancer-Related Lymphedema. Clin Breast Cancer. 2022 Apr;22(3):e270-e277. doi: 10.1016/j.clbc.2021.08.005. Epub 2021 Aug 19.

  PMID: 34535391 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: January 10, 2018
• Primary Completion: January 5, 2024
• Study Completion: June 20, 2024
• Last Updated: June 11, 2025

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)