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

NCT ID: NCT07014657

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2024-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer-Related Lymphedema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital Combined Decongestive Therapy Group

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.

Group Type EXPERIMENTAL

Digital Combined Decongestive Therapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Combined Decongestive Therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Selva Otsay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bezmialem Vakıf University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34535391 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lenfödemüst2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.