Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT07154043

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

Led by Pamukkale University · Updated on 2026-03-04

45

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female gender
  • Age between 18 and 65 years
  • History of unilateral mastectomy and lymph node dissection at least one year ago due to breast cancer
  • Unilateral breast cancer-related upper extremity lymphedema for at least six months with >20% volume difference or >2 cm circumference difference
  • No lymphedema treatment or exercise therapy in the last six months
  • Completed primary breast cancer treatment at least 6 months ago (except hormone therapy/aromatase inhibitors)
Not Eligible

You will not qualify if you...

  • Bilateral breast cancer
  • Bilateral axillary lymph node dissection
  • Metastatic breast cancer
  • Ongoing radiotherapy or chemotherapy
  • Primary or bilateral lymphedema
  • Active cancer
  • Stage 3 lymphedema
  • Uncontrolled serious systemic disease (cardiopulmonary, arterial/venous, renal, hypertension/hypotension, arrhythmia, scleroderma, Sudek's atrophy)
  • Current or recent infection (cellulitis, lymphangitis) or deep venous thrombosis within 3 months
  • Presence of open wounds
  • Use of medications affecting body fluid and electrolyte balance (e.g., diuretics)
  • Serious mental or sensory problems
  • Pregnancy
  • Body mass index greater than 40 kg/m2

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Pamukkale University

Denizli, Turkey (Türkiye)

Actively Recruiting

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Research Team

E

Emre Bezmez, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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