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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Arm volumetric measurements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Complete Decongestive Therapy plus Intermittent Pneumatic Compression Group
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.
干预措施: CDT + Intermittent Pneumatic Compression (IPC) (Procedure)
Complete Decongestive Therapy without Manual Lymph Drainage plus Intermittent Pneumatic Compression
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.
干预措施: CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression (Procedure)
Complete Decongestive Therapy Group
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.
干预措施: Complete Decongestive Therapy (CDT) (Procedure)
结局指标
主要结局
Arm volumetric measurements
时间窗: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
次要结局
- 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)
- Upper Extremity Heaviness (Visual Analog Scale)(1 day before rehabilitation and 3 weeks after the start of rehabilitation)
- Upper Extremity Tightness (Visual Analog Scale)(1 day before rehabilitation and 3 weeks after the start of rehabilitation)
- Perceived Improvement(3 weeks after the start of rehabilitation)
- Upper Extremity Pain (Visual Analog Scale)(1 day before rehabilitation and 3 weeks after the start of rehabilitation)
- Patient Satisfaction(3 weeks after the start of rehabilitation)
研究者
Oya Topuz
Professor Doctor
Pamukkale University