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Breast Cancer-Related LymphedemaNCT07154043

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

A study testing Complete Decongestive Therapy (CDT), CDT + Intermittent Pneumatic Compression (IPC) and CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression in people with Breast Cancer-Related Lymphedema and BCRL, run by Pamukkale University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer-Related Lymphedema, BCRL
What is being tested?
Complete Decongestive Therapy (CDT), CDT + Intermittent Pneumatic Compression (IPC) and CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2025to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Bilateral breast cancer
  • Bilateral axillary lymph node dissection
  • Metastatic breast cancer
  • Receiving ongoing radiotherapy or chemotherapy
  • Primary or bilateral lymphedema
  • Having active cancer
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emre Bezmez, M.D. contact

+905319902220

emrebezmez@gmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Pamukkale University

    Denizli

    Emre Bezmez, M.D., +905319902220

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Complete Decongestive Therapy (CDT), CDT + Intermittent Pneumatic Compression (IPC), CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression
Keywords
Breast Cancer-Related Lymphedema, Manual Lymph Drainage, Intermittent Pneumatic Compression, Complete Decongestive Therapy
Medical subject headings
Breast Cancer Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complete Decongestive Therapy (CDT)Procedure or surgery

    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)Procedure or surgery

    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 CompressionProcedure or surgery

    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.

Study groups in NCT07154043
Study groupRoleWhat they receive
Complete Decongestive Therapy plus Intermittent Pneumatic Compression GroupExperimentalComplete 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.
Receives: Procedure: CDT + Intermittent Pneumatic Compression (IPC)
Complete Decongestive Therapy without Manual Lymph Drainage plus Intermittent Pneumatic CompressionExperimentalThis 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.
Receives: Procedure: CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression
Complete Decongestive Therapy GroupActive comparatorThis 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.
Receives: Procedure: Complete Decongestive Therapy (CDT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  1. Shoulder Range of Motion

    Goniometric measurements of the affected shoulder will be performed to assess flexion, extension, abduction, adduction, internal rotation, and external rotation in patients with lymphedema.

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

  2. Quality of Life Measurement ULL-27

    ULL-27 quality of life questionnaire, developed specifically for upper extremity lymphedema patients. The scale has physical, psychological and social dimensions. It consists of 27 questions. A high score on the scale indicates that lymphedema negatively affects the quality of life.

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

  3. Arm Circumference Measurements

    To assess lymphedema severity, circumferential measurements of the affected and unaffected upper extremities will be performed. Patients' forearms will be in a supine position, elbows fully extended, and arms abducted at 90 degrees. Arm-hand circumference will be measured at four points: metacarpal region, wrist, 10 cm below the lateral epicondyle, and 15 cm above the lateral epicondyle, using a non-stretchable 7 mm tape of 150 cm length. Measurements will be taken on both upper extremities, and the differences between sides will be recorded in centimeters.

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

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

    The Quick-DASH is an 11-item questionnaire used to assess activity limitations of the upper extremity in patients with lymphedema related to breast cancer. Each item is scored from 1 to 5, and total scores are summed. A total score of 0 indicates no disability, while a score of 100 indicates the highest level of disability. The Turkish version was validated in 2011 and has been found valid and reliable for assessing upper extremity activity limitations in breast cancer-related lymphedema.

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

  5. Upper Extremity Swelling (Visual Analog Scale)

    Swelling in the affected extremity will be assessed using a 0-10 cm (0-100 mm) horizontal Visual Analog Scale (VAS). A score of 0 indicates no symptom, and 10 cm indicates the most severe presence of the symptom. Participants will mark the severity of each symptom and the discomfort caused by the symptom on the VAS ("0" = no complaint, "10" = maximal complaint). The mark will be measured in centimeters with a ruler. The VAS is a valid and reliable method for measuring experimental and clinical pain as well as lymphedema-specific symptoms, and it is sensitive to small changes in symptom intensity.

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

  6. Upper Extremity Heaviness (Visual Analog Scale)

    Heaviness in the affected extremity will be assessed using a 0-10 cm (0-100 mm) horizontal Visual Analog Scale (VAS). A score of 0 indicates no symptom, and 10 cm indicates the most severe presence of the symptom. Participants will mark the severity of each symptom and the discomfort caused by the symptom on the VAS ("0" = no complaint, "10" = maximal complaint). The mark will be measured in centimeters with a ruler. The VAS is a valid and reliable method for measuring experimental and clinical pain as well as lymphedema-specific symptoms, and it is sensitive to small changes in symptom intensity.

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

  7. Upper Extremity Tightness (Visual Analog Scale)

    Tightness in the affected extremity will be assessed using a 0-10 cm (0-100 mm) horizontal Visual Analog Scale (VAS). A score of 0 indicates no symptom, and 10 cm indicates the most severe presence of the symptom. Participants will mark the severity of each symptom and the discomfort caused by the symptom on the VAS ("0" = no complaint, "10" = maximal complaint). The mark will be measured in centimeters with a ruler. The VAS is a valid and reliable method for measuring experimental and clinical pain as well as lymphedema-specific symptoms, and it is sensitive to small changes in symptom intensity.

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

  8. Upper Extremity Pain (Visual Analog Scale)

    Pain in the affected extremity will be assessed using a 0-10 cm (0-100 mm) horizontal Visual Analog Scale (VAS). A score of 0 indicates no symptom, and 10 cm indicates the most severe presence of the symptom. Participants will mark the severity of each symptom and the discomfort caused by the symptom on the VAS ("0" = no complaint, "10" = maximal complaint). The mark will be measured in centimeters with a ruler. The VAS is a valid and reliable method for measuring experimental and clinical pain as well as lymphedema-specific symptoms, and it is sensitive to small changes in symptom intensity.

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

  9. Patient Satisfaction

    Patient satisfaction with the exercise programs will be assessed using a 4-point Likert scale (0 = not satisfied, 1 = slightly satisfied, 2 = satisfied, 3 = very satisfied).

    Measured: 3 weeks after the start of rehabilitation

  10. Perceived Improvement

    Patients' perceived improvement will be measured using the Patient Global Perceived Improvement Scale, asking participants to compare their current condition with baseline regarding lymphedema (1 = much better, 2 = better, 3 = slightly better, 4 = no change, 5 = slightly worse, 6 = worse, 7 = much worse). The Turkish version of this scale was validated and culturally adapted by Yalçın et al. in 2003, showing good internal consistency (Cronbach's α = 0.79) and test-retest reliability (ICC = 0.75).

    Measured: 3 weeks after the start of rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start15 Sep 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154043
Sponsor's protocol ID
PamukkaleU.ftr-OTopuz-001
Status last verified
Mar 2026
First submitted
26 Aug 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.1177/0269215519835907. Epub 2019 Mar 18.

    PubMed 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.

    PubMed 37140559

  • 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.

    PubMed 32477925

  • 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.

    PubMed 12861145

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

    PubMed 11019400

  • 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.

    PubMed 12436430

  • 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.

    PubMed 20218087

  • 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.

    PubMed 31795748

  • 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.

    PubMed 23925581

Questions about this trial

What is this clinical trial studying?

A study testing Complete Decongestive Therapy (CDT), CDT + Intermittent Pneumatic Compression (IPC) and CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression in people with Breast Cancer-Related Lymphedema and BCRL, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emre Bezmez, M.D. (+905319902220, emrebezmez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm volumetric measurements (time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154043, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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