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

Not Applicable

Completed

• Conditions: Breast Cancer-Related Lymphedema

• Registration Number: NCT07014657
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed Description

This study evaluated the feasibility and effectiveness of a digital combined decongestive therapy (CDT) program in patients with breast cancer-related lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital CDT program with remote guidance. Compression garments were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymph-ICF questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-10
• Primary Completion: 2024-01-05
• Study Completion: 2024-06-20
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Limb Volume	At baseline, at week 4 (end of treatment), and at week 12 (follow-up)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	At baseline, at week 4 (end of treatment), and at week 12 (follow-up)	Quality of life was assessed using the Turkish validated and reliable lymphedema-specific questionnaire, Lymph-ICF. The questionnaire consists of 29 items including 7 questions about arm symptoms and 22 questions related to functional impairments in daily activities. It covers five subscales: physical function, mental status, household activities, mobility activities, and social life. Patients rated their complaints on a 0 to 100 mm visual analog scale (VAS), where 0 indicates no complaints and 100 indicates the worst complaints. Higher scores represent worse quality of life.

Trial Locations

Locations (1)

Bezmialem Vakıf University Hospital; 🇹🇷 İstanbul, Turkey