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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07014657
Enrollment
29
Registered
2025-06-11
Start date
2018-01-10
Completion date
2024-06-20
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer-Related Lymphedema

Keywords

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

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.

Interventions

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.

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Limb VolumeAt 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

MeasureTime frameDescription
Change in Quality of LifeAt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026