Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL
NCT ID: NCT07154043
Last Updated: 2025-09-04
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2025-09-15
2026-12-01
Brief Summary
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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.
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Detailed Description
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BCRL is associated with swelling, heaviness, discomfort, weakness, increased risk of infection, and progressive chronicity, which together result in upper extremity dysfunction and reduced quality of life. Compared with women without lymphedema, patients with BCRL report more frequent pain, decreased shoulder mobility, reduced upper extremity strength, impaired daily activities, and sensory disturbances.
The standard treatment for BCRL is complete decongestive therapy (CDT), which consists of manual lymph drainage (MLD), compression, skin care, and exercise. Intermittent pneumatic compression (IPC) has also been proposed as a treatment option, and the 2023 consensus report of the International Society of Lymphology emphasized the need for further studies evaluating IPC in combination with MLD.
However, the number of studies directly comparing IPC with MLD, or evaluating their combined use, is limited and results remain inconsistent. Some trials reported no significant difference between MLD and IPC in terms of limb volume reduction, while others demonstrated additional benefits of IPC in relieving heaviness and tension. The role of IPC in CDT, whether as a replacement for MLD or as an adjunct, is not yet clearly defined.
The purpose of this study is to investigate the acute effects of using IPC instead of MLD, or in combination with MLD, within CDT on arm circumference, arm volume, shoulder range of motion, and quality of life in patients with BCRL.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Complete Decongestive Therapy plus Intermittent Pneumatic Compression Group
Complete decongestive therapy program consisting of manual lymph drainage, multilayer bandaging, skin care, and exercise. In addition, patients will receive intermittent pneumatic compression with a device at 20-50 mmHg pressure for 40 minutes per session. The total treatment duration will be 115 minutes per session, 5 sessions per week, for 3 weeks.
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.
Complete Decongestive Therapy without Manual Lymph Drainage plus Intermittent Pneumatic Compression
This group will receive a complete decongestive therapy program consisting of multilayer bandaging, skin care, and exercise. Manual lymph drainage will be replaced by intermittent pneumatic compression. Intermittent pneumatic compression will be applied with a device at 20-50 mmHg pressure for 40 minutes per session. The total treatment duration will be 75 minutes per session, 5 sessions per week, for 3 weeks.
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.
Complete Decongestive Therapy Group
This group will receive a complete decongestive therapy program consisting of manual lymph drainage, multilayer bandaging, skin care, and exercise. The treatment duration will be 75 minutes per session, 5 sessions per week, for 3 weeks.
Complete Decongestive Therapy (CDT)
Manual lymph drainage, multilayer bandaging, skin care, and exercise. 75 minutes per session, 5 sessions per week, for 3 weeks.
Interventions
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Complete Decongestive Therapy (CDT)
Manual lymph drainage, multilayer bandaging, skin care, and exercise. 75 minutes per session, 5 sessions per week, for 3 weeks.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
FEMALE
No
Sponsors
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Pamukkale University
OTHER
Responsible Party
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Oya Topuz
Professor Doctor
Principal Investigators
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Oya Topuz, Professor
Role: STUDY_DIRECTOR
Pamukkale University
Locations
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Pamukkale University
Denizli, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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LeBlanc M, Stineman M, DeMichele A, Stricker C, Mao JJ. Validation of QuickDASH outcome measure in breast cancer survivors for upper extremity disability. Arch Phys Med Rehabil. 2014 Mar;95(3):493-8. doi: 10.1016/j.apmr.2013.09.016. Epub 2013 Oct 2.
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Executive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19.
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Szolnoky G, Lakatos B, Keskeny T, Varga E, Varga M, Dobozy A, Kemeny L. Intermittent pneumatic compression acts synergistically with manual lymphatic drainage in complex decongestive physiotherapy for breast cancer treatment-related lymphedema. Lymphology. 2009 Dec;42(4):188-94.
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Sanal-Toprak C, Ozsoy-Unubol T, Bahar-Ozdemir Y, Akyuz G. The efficacy of intermittent pneumatic compression as a substitute for manual lymphatic drainage in complete decongestive therapy in the treatment of breast cancer related lymphedema. Lymphology. 2019;52(2):82-91.
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Other Identifiers
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PamukkaleU.ftr-OTopuz-001
Identifier Type: -
Identifier Source: org_study_id
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