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

NCT07154043 | Recruiting

• 1 other identifier: PamukkaleU.ftr-OTopuz-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer-Related Lymphedema; BCRL

Keywords

Breast Cancer-Related Lymphedema; Manual Lymph Drainage; Intermittent Pneumatic Compression; Complete Decongestive Therapy

Outcome Measures

Primary Outcomes (1)

• Arm volumetric measurements

  Arm volume will be calculated using circumferential measurements taken with a standard 7 mm measuring tape at 4 cm intervals along the arm. Segmental arm volumes (mL-cm³) will be calculated using the simplified frustum formula (Frustum Model). This formula, as described by Sitzia et al., has shown high correlation with water displacement measurements and is widely used in the literature as a valid and reliable indirect method for assessing lymphedema.

  1 day before rehabilitation and 3 weeks after the start of rehabilitation

Secondary Outcomes (10)

• Shoulder Range of Motion

  1 day before rehabilitation and 3 weeks after the start of rehabilitation

• Quality of Life Measurement ULL-27

  1 day before rehabilitation and 3 weeks after the start of rehabilitation

• Arm Circumference Measurements

  1 day before rehabilitation and 3 weeks after the start of rehabilitation

• Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) Questionnaire

  1 day before rehabilitation and 3 weeks after the start of rehabilitation

• Upper Extremity Swelling (Visual Analog Scale)

  1 day before rehabilitation and 3 weeks after the start of rehabilitation

Study Arms (3)

Complete Decongestive Therapy plus Intermittent Pneumatic Compression Group

EXPERIMENTAL

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.

Procedure: CDT + Intermittent Pneumatic Compression (IPC)

Complete Decongestive Therapy without Manual Lymph Drainage plus Intermittent Pneumatic Compression

EXPERIMENTAL

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.

Procedure: CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression

Complete Decongestive Therapy Group

ACTIVE COMPARATOR

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.

Procedure: Complete Decongestive Therapy (CDT)

Interventions

Complete Decongestive Therapy (CDT) PROCEDURE

Manual lymph drainage, multilayer bandaging, skin care, and exercise. 75 minutes per session, 5 sessions per week, for 3 weeks.

Complete Decongestive Therapy Group

CDT + Intermittent Pneumatic Compression (IPC) PROCEDURE

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 plus Intermittent Pneumatic Compression Group

CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression PROCEDURE

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 without Manual Lymph Drainage plus Intermittent Pneumatic Compression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

Related Publications (30)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 10.1177/0269215519835907. Epub 2019 Mar 18.

  PMID: 30880473 BACKGROUND

• 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 BACKGROUND

• Kayali Vatansever A, Yavuzsen T, Karadibak D. The Reliability and Validity of Quality of Life Questionnaire Upper Limb Lymphedema (ULL-27) Turkish Patient With Breast Cancer Related Lymphedema. Front Oncol. 2020 May 12;10:455. doi: 10.3389/fonc.2020.00455. eCollection 2020.

  PMID: 32477925 BACKGROUND

• Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.

  PMID: 12861145 BACKGROUND

• Stanton AW, Badger C, Sitzia J. Non-invasive assessment of the lymphedematous limb. Lymphology. 2000 Sep;33(3):122-35.

  PMID: 11019400 BACKGROUND

• Szuba A, Achalu R, Rockson SG. Decongestive lymphatic therapy for patients with breast carcinoma-associated lymphedema. A randomized, prospective study of a role for adjunctive intermittent pneumatic compression. Cancer. 2002 Dec 1;95(11):2260-7. doi: 10.1002/cncr.10976.

  PMID: 12436430 BACKGROUND

• 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.

  PMID: 20218087 BACKGROUND

• Tastaban E, Soyder A, Aydin E, Sendur OF, Turan Y, Ture M, Bilgen M. Role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema: a randomized controlled trial. Clin Rehabil. 2020 Feb;34(2):220-228. doi: 10.1177/0269215519888792. Epub 2019 Dec 4.

  PMID: 31795748 BACKGROUND

• Uzkeser H, Karatay S, Erdemci B, Koc M, Senel K. Efficacy of manual lymphatic drainage and intermittent pneumatic compression pump use in the treatment of lymphedema after mastectomy: a randomized controlled trial. Breast Cancer. 2015 May;22(3):300-7. doi: 10.1007/s12282-013-0481-3. Epub 2013 Aug 8.

  PMID: 23925581 BACKGROUND

• 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.

  PMID: 31525829 BACKGROUND

• Ridner SH, Fu MR, Wanchai A, Stewart BR, Armer JM, Cormier JN. Self-management of lymphedema: a systematic review of the literature from 2004 to 2011. Nurs Res. 2012 Jul-Aug;61(4):291-9. doi: 10.1097/NNR.0b013e31824f82b2.

  PMID: 22565103 BACKGROUND

• Executive Committee of the International Society of Lymphology. The Diagnosis and Treatment of Peripheral Lymphedema: 2023 Consensus Document of The International Society of Lymphology. Lymphology. 2023;56(4):133-151.

  PMID: 39207406 BACKGROUND

• Gursen C, Dylke ES, Moloney N, Meeus M, De Vrieze T, Devoogdt N, De Groef A. Self-reported signs and symptoms of secondary upper limb lymphoedema related to breast cancer treatment: Systematic review. Eur J Cancer Care (Engl). 2021 Sep;30(5):e13440. doi: 10.1111/ecc.13440. Epub 2021 Mar 18.

  PMID: 33733550 BACKGROUND

• Orhan C, Uzelpasaci E, Baran E, Nakip G, Ozgul S, Aksoy S, Akbayrak T. The Reliability and Validity of the Turkish Version of the Lymphedema Life Impact Scale in Patients With Breast Cancer-Related Lymphedema. Cancer Nurs. 2020 Sep/Oct;43(5):375-383. doi: 10.1097/NCC.0000000000000709.

  PMID: 30921030 BACKGROUND

• Smoot B, Wong J, Cooper B, Wanek L, Topp K, Byl N, Dodd M. Upper extremity impairments in women with or without lymphedema following breast cancer treatment. J Cancer Surviv. 2010 Jun;4(2):167-78. doi: 10.1007/s11764-010-0118-x. Epub 2010 Apr 7.

  PMID: 20373044 BACKGROUND

• Lee TS, Morris CM, Czerniec SA, Mangion AJ. Does Lymphedema Severity Affect Quality of Life? Simple Question. Challenging Answers. Lymphat Res Biol. 2018 Feb;16(1):85-91. doi: 10.1089/lrb.2016.0049. Epub 2017 Apr 28.

  PMID: 28453410 BACKGROUND

• Pinto M, Gimigliano F, Tatangelo F, Megna M, Izzo F, Gimigliano R, Iolascon G. Upper limb function and quality of life in breast cancer related lymphedema: a cross-sectional study. Eur J Phys Rehabil Med. 2013 Oct;49(5):665-73. Epub 2013 May 23.

  PMID: 23698473 BACKGROUND

• Park JE, Jang HJ, Seo KS. Quality of life, upper extremity function and the effect of lymphedema treatment in breast cancer related lymphedema patients. Ann Rehabil Med. 2012 Apr;36(2):240-7. doi: 10.5535/arm.2012.36.2.240. Epub 2012 Apr 30.

  PMID: 22639749 BACKGROUND

• Dawes DJ, Meterissian S, Goldberg M, Mayo NE. Impact of lymphoedema on arm function and health-related quality of life in women following breast cancer surgery. J Rehabil Med. 2008 Aug;40(8):651-8. doi: 10.2340/16501977-0232.

  PMID: 19020699 BACKGROUND

• DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.

  PMID: 23540561 BACKGROUND

• Pappalardo M, Starnoni M, Franceschini G, Baccarani A, De Santis G. Breast Cancer-Related Lymphedema: Recent Updates on Diagnosis, Severity and Available Treatments. J Pers Med. 2021 May 12;11(5):402. doi: 10.3390/jpm11050402.

  PMID: 34065795 BACKGROUND

• McDuff SGR, Mina AI, Brunelle CL, Salama L, Warren LEG, Abouegylah M, Swaroop M, Skolny MN, Asdourian M, Gillespie T, Daniell K, Sayegh HE, Naoum GE, Zheng H, Taghian AG. Timing of Lymphedema After Treatment for Breast Cancer: When Are Patients Most At Risk? Int J Radiat Oncol Biol Phys. 2019 Jan 1;103(1):62-70. doi: 10.1016/j.ijrobp.2018.08.036. Epub 2018 Aug 28.

  PMID: 30165125 BACKGROUND

• Mortimer P. Arm lymphoedema after breast cancer. Lancet Oncol. 2013 May;14(6):442-3. doi: 10.1016/S1470-2045(13)70097-4. Epub 2013 Mar 27. No abstract available.

  PMID: 23540560 BACKGROUND

• Burckhardt M, Belzner M, Berg A, Fleischer S. Living with breast cancer-related lymphedema: a synthesis of qualitative research. Oncol Nurs Forum. 2014 Jul 1;41(4):E220-37. doi: 10.1188/14.ONF.E220-E237.

  PMID: 24969257 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema

Interventions

carbohydrate-deficient transferrin; Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Oya Topuz, Professor

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Emre Bezmez, M.D.

CONTACT

+905319902220; emrebezmez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)