About this trial
Breast cancer is the most common type of cancer among women globally and has the highest mortality rate. Surgical interventions are typically required in the treatment of breast cancer, but these procedures can lead to complications such as infection, seroma, hematoma, cellulitis, and particularly lymphedema due to disruptions in the physiology of axillary lymphatic vessels.
Breast Cancer-Related Lymphedema (BCRL) commonly develops within the first two years following surgical intervention and its incidence varies depending on the surgical method used. The incidence of lymphedema after Sentinel Lymph Node Biopsy (SLNB) is around 5%, whereas it increases to 30-50% after Axillary Lymph Node Dissection (ALND).
BCRL significantly impacts the quality of life (QoL) through physical symptoms such as swelling, pain, tightness, and limited range of motion, as well as psychosocial issues including depression, social isolation, and sleep disturbances. Sleep disorders, in particular, are associated with depression and contribute to a further decline in QoL.
In the treatment of BCRL, both conservative (non-surgical) and surgical methods are traditionally employed. Complex Decongestive Physiotherapy (CDP) is considered the gold standard for the conservative management of lymphedema. CDP comprises a two-phase treatment process. The first phase, known as the "Decongestion Phase," generally lasts 2-4 weeks and includes manual lymphatic drainage (MLD), skin care, compression therapy with multi-layered short-stretch bandages, and muscle-pumping exercises. The second phase, the "Maintenance Phase," is more prolonged and aims to sustain the results achieved in Phase 1. It includes compression with low-stretch elastic garments, skin care, exercises, and patient-administered MLD as needed.
The primary objectives of CDP are to improve lymphatic circulation, reduce swelling, pain, and tightness, increase the range of motion, and ultimately improve the QoL. Studies have shown that CDP significantly enhances sleep quality and QoL in women with BCRL.
However, most existing studies examine all stages of BCRL without comparing the effects of CDP across different stages. The impact of CDP on sleep and QoL may vary depending on the stage of BCRL, highlighting the need for specific research on its effects in particular populations. Furthermore, many studies lack follow-up data, leaving the Maintenance Phase of CDP largely unexplored.
This study aims to investigate the effects of CDP, including both the Decongestion and Maintenance phases, on sleep quality and QoL specifically in women with Stage II BCRL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be aged between 18 or 85 years,
with a diagnosis of unilateral lymphedema in the upper extremity following breast cancer surgery
stage 2 lymphedema confirmed by a doctor
voluntary consent to participate in the study.
Disqualifiers
refusal to participate in the study
development of lymphedema due to primary causes, presence of bilateral upper extremity lymphedema
active soft tissue infection in the lymphedematous arm
mental or cognitive disorders
Trial design
Single group
Treatments tested in this trial
Physiotherapy and rehabilitation
Other interventionComplex Decongestive Physiotherapy (CDP) Complex Decongestive Physiotherapy (CDP) consists of Manual Lymphatic Drainage (MLD), skin care, compression bandaging, and exercise, which are routinely used in clinical practice (9). CDP sessions will last approximately one hour each and will be administered for 4 weeks, with 5 sessions per week, totaling 20 sessions. Manual Lymphatic Drainage (MLD) is a massage technique involving rhythmic, gentle pressure movements aimed at reducing the accumulation of lymphatic fluid in conditions such as lymphedema. This therapy facilitates the drainage of lymphatic fluid into the body's primary lymphatic pathways, thereby reducing edema, pain, and tightness, while enhancing range of motion and overall quality of life. MLD typically focuses on areas with a high concentration of lymph nodes, promoting the smooth circulation of lymph fluid. Treatment sessions usually last between 30 minutes to one hour.
Treatment groups
Trial outcomes
Primary outcomes
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 18 questions that assess sleep quality over the past four weeks. It has seven subcomponents, each scored from 0 to 3. The subcomponents include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction (17). The total score ranges from 0 to 21, with higher scores indicating worse sleep quality. A total score above 5 indicates poor sleep quality. The Turkish validity and reliability of the PSQI was established by Ağargün et al. (18).
Secondary outcomes
Quality of life assessment
Patients' quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQoL). The LYMQoL consists of 4 subcomponents (function, mood, appearance, and symptoms) and 21 questions. Each question is evaluated on a 4-point Likert scale, where "1" indicates no effect and "4" indicates a high level of effect. The last question of the questionnaire assesses overall quality of life using a numeric visual analog scale (19). The total score is calculated by summing the scores of all questions and dividing by the number of questions. The total score ranges from 1 to 4, with higher scores indicating worse quality of life. The Turkish validity and reliability of the LYMQoL was established by Bakar et al. (20).
Tissue Dielectric Constant
The tissue dielectric constant (TDC) will be measured using the Moisturemeter-D device. The measurement method for TDC uses a co-axial reflection technique at a frequency of 300 MHz, which allows for the non-invasive measurement of free and bound local tissue fluid at effective penetration depths ranging from 0.5 to 5.0 mm (21). Measurements will be taken at a depth of 2.5 mm while the patient is in a supine position. TDC measurements will be made bilaterally at six reference points: the dorsum of the hand, the upper palmar wrist joint, 5 cm below and 7 cm above the elbow joint (forearm volar and arm volar), 7 cm below and 7 cm above the olecranon (forearm dorsal and arm dorsal), with three repeated measurements at each point. The TDC ratio will be calculated by dividing the affected side's TDC by the unaffected side's TDC. A TDC ratio of 1.20 is considered the threshold value for diagnosing lymphedema (22).
Volumetric Measurement
The volume of the extremity will be determined using the water displacement method. The measurement container will be filled with tap water to the overflow point. The participant will be asked to slowly submerge their arm into the container while leaning forward, ensuring the rod of the container fits between the second and third fingers. To prevent water spillage, participants will be instructed to avoid sudden movements. The displaced water will be transferred to another container, and the amount of displaced water will be recorded in milliliters (mL). Measurements will be made bilaterally, and the containers will be disinfected after each measurement. Residual extremity volume will be calculated using the formula: \[(Affected extremity volume - Unaffected extremity volume) / Unaffected extremity volume\] x 100. The volumetric measurement is considered the gold standard method for volume calculation in lymphedema patients (23).
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