Recruiting

Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL

ClinicalTrials.gov IDNCT07154043

PhaseNA

Enrollment45

SponsorPamukkale University

Age18 Years

SexFEMALE

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Conditions studied

Breast Cancer-Related Lymphedema, BCRL

About this study

Breast cancer is the most common cancer among women worldwide and lymphedema is one of its most significant complications. Breast cancer-related lymphedema (BCRL) may develop shortly after treatment or even years later, causing physical and psychological burden, functional impairment, and reduced quality of life. Complete decongestive therapy (CDT), which includes manual lymph drainage (MLD), compression, skin care, and exercise, is the standard approach. Intermittent pneumatic compression (IPC) has been proposed as an additional option, and current consensus reports emphasize the need for studies evaluating IPC in combination with MLD. Previous studies comparing IPC and MLD, either alone or in combination, have shown inconsistent results. Some reported no significant difference between treatment groups, while others suggested additional benefits of IPC, particularly in reducing limb heaviness and tension. However, there is still insufficient evidence to clarify the exact role of IPC within CDT. The aim of this study is to investigate the acute effects of using IPC instead of MLD, or in combination with MLD, on arm circumference, arm volume, shoulder range of motion, and quality of life in patients with BCRL.

Interventions

Procedure: Complete Decongestive Therapy (CDT) — Manual lymph drainage, multilayer bandaging, skin care, and exercise. 75 minutes per session, 5 sessions per week, for 3 weeks.
Procedure: CDT + Intermittent Pneumatic Compression (IPC) — Complete decongestive therapy program including manual lymph drainage, multilayer bandaging, skin care, and exercise, plus intermittent pneumatic compression at 20-50 mmHg for 40 minutes per session. Total duration: 115 minutes per session, 5 sessions per week, for 3 weeks.
Procedure: CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression — Complete decongestive therapy consisting of multilayer bandaging, skin care, and exercise, with manual lymph drainage replaced by intermittent pneumatic compression at 20-50 mmHg for 40 minutes per session. Total duration: 75 minutes per session, 5 sessions per week, for 3 weeks.

Primary outcomes

Arm volumetric measurements (1 day before rehabilitation and 3 weeks after the start of rehabilitation)

Eligibility information

Inclusion Criteria: * Female gender * Patients aged 18-65 years * Having a history of unilateral mastectomy and lymph node dissection at least one year ago due to breast cancer diagnosis. * Having unilateral breast cancer-related upper extremity lymphedema (\>20% volume difference between the two upper extremities or \>2 cm difference in circumference at any measured point) according to the diagnostic criteria of the International Society of Lymphology (Committee 2023) for at least six months. * Not having received lymphedema treatment or exercise therapy for the last six months * Completing breast cancer primary treatment at least 6 months ago (except hormone therapy/aromatase inhibitors) Exclusion Criteria: * Bilateral breast cancer * Bilateral axillary lymph node dissection * Metastatic breast cancer * Receiving ongoing radiotherapy or chemotherapy * Primary or bilateral lymphedema * Having active cancer * Presence of stage 3 lymphedema * Uncontrolled serious systemic disease (cardiopulmonary diseases, arterial or venous diseases, renal dysfunction, uncontrolled hypertension or hypotension, cardiac arrhythmia, scleroderma, Sudek's atrophy). * Current or recent (within the last 3 months) infection (cellulitis, lymphangitis) or deep venous thrombosis * Presence of open wounds * Using medications that may affect body fluid and electrolyte balance (diuretics, etc.). * Individuals with serious mental and sensory problems * Being pregnant * Body mass index \>40 kg/m2

Study locations

Pamukkale University, Denizli, Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.