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

Official title

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

Overview

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.

Detailed description

Breast cancer is the most common malignancy among women worldwide and remains the leading cause of cancer-related mortality in women. Breast cancer-related lymphedema (BCRL) is one of the most important complications of breast cancer treatment. It may occur due to lymphatic system damage caused by surgery and/or radiotherapy, or as a result of tumor-related lymphangiogenesis, leading to interstitial fluid accumulation. BCRL can develop immediately after treatment or months to years later.

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.

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 outcome measures

• Arm volumetric measurements [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]

Secondary outcome measures (10)

• Shoulder Range of Motion [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Quality of Life Measurement ULL-27 [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Arm Circumference Measurements [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) Questionnaire [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Upper Extremity Swelling (Visual Analog Scale) [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Upper Extremity Heaviness (Visual Analog Scale) [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Upper Extremity Tightness (Visual Analog Scale) [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Upper Extremity Pain (Visual Analog Scale) [Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation]
• Patient Satisfaction [Time frame: 3 weeks after the start of rehabilitation]
• Perceived Improvement [Time frame: 3 weeks after the start of rehabilitation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Pamukkale University — Denizli

Publications

• Gummesson 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
• 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. PMID 24095658
• Koldas 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
• Sitzia 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
• Karges 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
• 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. PMID 32521126
• De 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: 10.11 PMID 30880473
• Keeley V, Riches K, Ward L, Franks PJ. A Prospective Preliminary Study Examining the Physiological Impact of Pneumatic Compression Dosing in the Treatment of Lower Extremity Lymphedema. Lymphat Res Biol. 2023 Oct;21(5):456-462. doi: 10.1089/lrb.2022.0087. Epub 2023 May 4. PMID 37140559

Identifiers

NCT: NCT07154043 · PamukkaleU.ftr-OTopuz-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗