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

Pamukkale University

Status: Not yet enrolling

Conditions: Breast Cancer-Related Lymphedema; BCRL

Treatments: Procedure: Complete Decongestive Therapy (CDT); Procedure: CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression; Procedure: CDT + Intermittent Pneumatic Compression (IPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07154043

PamukkaleU.ftr-OTopuz-001

Details and patient eligibility

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Complete Decongestive Therapy plus Intermittent Pneumatic Compression Group

Experimental group

Description:

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.

Treatment:

Procedure: CDT + Intermittent Pneumatic Compression (IPC)

Complete Decongestive Therapy without Manual Lymph Drainage plus Intermittent Pneumatic Compression

Experimental group

Description:

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.

Treatment:

Procedure: CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression

Complete Decongestive Therapy Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Complete Decongestive Therapy (CDT)