Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL
Recruiting · NCT07154043 · Interventional (participants receive a specific treatment) · Lead sponsor: Pamukkale University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Pamukkale University - Denizli, Turkey (Türkiye)