An interventional study of Complete Decongestive Therapy (CDT) and CDT + Intermittent Pneumatic Compression (IPC) in Breast Cancer-Related Lymphedema and BCRL, sponsored by Pamukkale University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment
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.
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.
148 studies on the registry are indexed under Breast Cancer Lymphedema; 44 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 119 interventional studies indexed under Breast Cancer Lymphedema.
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Exclusion Criteria:
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.
Procedure: CDT + Intermittent Pneumatic Compression (IPC)
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.
Procedure: CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression
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.
Procedure: Complete Decongestive Therapy (CDT)
Manual lymph drainage, multilayer bandaging, skin care, and exercise. 75 minutes per session, 5 sessions per week, for 3 weeks.
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.
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.
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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.
Time frame: 1 day before rehabilitation and 3 weeks after the start of rehabilitation
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).
Time frame: 3 weeks after the start of rehabilitation
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).
Time frame: 3 weeks after the start of rehabilitation
Plan to share: No
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