RecruitingNot ApplicableNCT07154043

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

Sponsor

Pamukkale University

Enrollment

45 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Related Lymphedema BCRL

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of managing arm swelling (lymphedema) after breast cancer treatment: manual lymph drainage therapy (MLD) alone versus using a pneumatic compression pump (IPC) instead of or alongside MLD. The goal is to find the most effective combination. **You may be eligible if...** - You are a woman between 18 and 65 years old - You had a mastectomy and lymph node removal at least one year ago due to breast cancer - You have arm swelling (lymphedema) that has persisted for at least 6 months - You have not had any lymphedema treatment or exercise therapy for the past 6 months - You finished primary breast cancer treatment at least 6 months ago (ongoing hormone therapy is OK) **You may NOT be eligible if...** - Your breast cancer was in both breasts or has spread to other parts of the body - You are currently receiving chemotherapy or radiation - You have stage 3 lymphedema (hardened, thickened skin) or an active infection like cellulitis - You have serious heart, lung, vascular, or kidney disease - You are pregnant - Your BMI is above 40 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComplete Decongestive Therapy (CDT)

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

PROCEDURECDT + 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.

PROCEDURECDT 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.