Clinical trial · Interventional
Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL
Comparison of Intermittent Pneumatic Compression Therapy as an Alternative or an Adjunct to Manual Lymphatic Drainage Within Complete Decongestive Therapy for Breast Cancer-Related Lymphedema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCRL | — | UNRESOLVED | — |
| Breast Cancer-Related Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDT + Intermittent Pneumatic Compression (IPC) | Procedure | — | UNRESOLVED |
| CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression | Procedure | — | UNRESOLVED |
| Complete Decongestive Therapy (CDT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Complete Decongestive Therapy plus Intermittent Pneumatic Compression Group
- description
- 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.
- interventionNames
- Procedure: CDT + Intermittent Pneumatic Compression (IPC)
- type
- EXPERIMENTAL
- label
- Complete Decongestive Therapy without Manual Lymph Drainage plus Intermittent Pneumatic Compression
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (30)
- BACKGROUNDGummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006 May 18;7:44. doi: 10.1186/1471-2474-7-44. PMID 16709254
- BACKGROUNDLeBlanc 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. PMID 24095658
- BACKGROUNDKoldas Dogan S, Ay S, Evcik D, Baser O. Adaptation of Turkish version of the questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) in patients with carpal tunnel syndrome. Clin Rheumatol. 2011 Feb;30(2):185-91. doi: 10.1007/s10067-010-1470-y. Epub 2010 Apr 22. PMID 20411289
- BACKGROUNDSitzia J. Volume measurement in lymphoedema treatment: examination of formulae. Eur J Cancer Care (Engl). 1995 Mar;4(1):11-6. doi: 10.1111/j.1365-2354.1995.tb00047.x. PMID 7620649
- BACKGROUNDKarges JR, Mark BE, Stikeleather SJ, Worrell TW. Concurrent validity of upper-extremity volume estimates: comparison of calculated volume derived from girth measurements and water displacement volume. Phys Ther. 2003 Feb;83(2):134-45. PMID 12564949
- BACKGROUNDExecutive 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. PMID 32521126
- BACKGROUNDDe Vrieze T, Gebruers N, Tjalma WA, Nevelsteen I, Thomis S, De Groef A, Dams L, Van der Gucht E, Belgrado JP, Vandermeeren L, Devoogdt N. What is the best method to determine excessive arm volume in patients with breast cancer-related lymphoedema in clinical practice? Reliability, time efficiency and clinical feasibility of five different methods. Clin Rehabil. 2019 Jul;33(7):1221-1232. doi: 10.1177/0269215519835907. Epub 2019 Mar 18.