Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorPamukkale University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Bilateral breast cancer
Bilateral axillary lymph node dissection
Metastatic breast cancer
Receiving ongoing radiotherapy or chemotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
Complete Decongestive Therapy (CDT)
Procedure/SurgeryManual lymph drainage, multilayer bandaging, skin care, and exercise. 75 minutes per session, 5 sessions per week, for 3 weeks.
CDT + Intermittent Pneumatic Compression (IPC)
Procedure/SurgeryComplete 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.
CDT without Manual Lymph Drainage plus Intermittent Pneumatic Compression
Procedure/SurgeryComplete 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Complete Decongestive Therapy plus Intermittent Pneumatic Compression GroupExperimental treatment 1 intervention
Group B: Complete Decongestive Therapy without Manual Lymph Drainage plus Intermittent Pneumatic CompressionExperimental treatment 1 intervention
Group C: Complete Decongestive Therapy GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 rehabilitationSecondary outcomes
1
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 rehabilitation2
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 rehabilitation3
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 rehabilitation4
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 rehabilitationSponsors and contacts
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Source ClinicalTrials.gov