Investigation of the Effects of Complex Decongestive Physiotherapy on Sleep Quality and Quality of Life in Women With Breast Cancer Related Lymphedema

March 27, 2026 updated by: Elif Duygu, Abant Izzet Baysal University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most common type of cancer and has the highest mortality rate among women worldwide. According to the 2022 Global Cancer Observatory statistics, breast cancer affects approximately 20 million women globally. It accounts for 23.8% of all cancers in women, making it the most frequently diagnosed type (1). Various treatment options are available for breast cancer patients. Most breast cancer cases require surgical procedures for advanced diagnosis and treatment. However, these procedures may lead to complications such as infection, seroma, hematoma, cellulitis, and, most importantly, lymphedema due to disruption in the physiology of axillary lymphatic vessels (2).

Lymphedema is a chronic disease characterized by the accumulation of lymphatic fluid, leading to skin and tissue changes. It results from lymphatic system insufficiency and impaired lymph transport (3, 4). Lymphedema occurs due to the buildup of excess water, filtered plasma proteins, extravascular blood cells, and products of parenchymal and stromal cells in the extracellular space (3).

Breast Cancer-Related Lymphedema (BCRL) often develops within two years following breast cancer diagnosis or surgery (5). The incidence of BCRL varies depending on the surgical method used for diagnosis and treatment. While the rate of lymphedema following Sentinel Lymph Node Biopsy (SLNB) is around 5%, it increases to 30-50% after Axillary Lymph Node Dissection (ALND). When ALND is combined with Regional Node Irradiation (RNI), the rate reaches 20-50% (2). One study identified ALND as the primary trigger for BCRL and emphasized avoiding this procedure whenever possible (6). Risk factors for BCRL include ALND, radiotherapy (RT), chemotherapy, postoperative seroma, obesity/high body mass index, smoking, total mastectomy, and postoperative bleeding (7, 8).

Clinically, BCRL manifests as chronic swelling, localized pain, heaviness, and tightness (9). It significantly impacts the quality of life (QoL) and causes psychosocial issues such as depression, social isolation, and decreased sleep quality in addition to physical symptoms like swelling, heaviness, tightness, and reduced range of motion (7). Pain in the affected limb makes it difficult for patients to fall asleep. Overuse of the dominant limb can exacerbate symptoms like swelling, pain, heaviness, stiffness, and numbness, further disrupting sleep quality. Sleep disturbances in BCRL patients are associated with depression and lower QoL scores. A study by Tamam et al. also reported a significant decline in both QoL and sleep quality among women with varying stages of BCRL (10, 11).

The treatment of BCRL is traditionally divided into conservative (non-operative) and operative methods (3). Complex Decongestive Physiotherapy (CDP) is considered the gold standard for conservative treatment of lymphedema. This non-invasive approach consists of two phases. Phase 1, known as the "Decongestion Phase", includes skin care, manual lymphatic drainage (MLD), compression therapy with multi-layered short-stretch bandages, and muscle-pumping exercises. Phase 2, the "Maintenance Phase", aims to preserve and optimize the results achieved in Phase 1. It involves compression with a low-stretch elastic garment, skin care, exercises, and patient-administered MLD as needed. Phase 1 typically lasts 2-4 weeks, while Phase 2 can extend for months or even years (3, 12, 13).

The primary goals of CDP are to improve lymph circulation and prevent lymphatic stasis. CDP reduces swelling, heaviness, tightness, and pain, while increasing the range of motion (3). This approach has been shown to enhance sleep and QoL in individuals with BCRL (12, 14). In a study evaluating sleep and QoL before and after CDP in women with BCRL, significant improvements were observed in lymphedema stages, as well as sleep and QoL scores post-treatment (15).

Although many studies have examined sleep and QoL in women with BCRL, very few have focused on these outcomes following CDP. Existing studies often include all BCRL stages without comparing outcomes across different stages. CDP may have varying effects on sleep and QoL depending on the stage of BCRL, highlighting the need to investigate these effects in specific populations. Additionally, studies on the impact of CDP on sleep and QoL often lack follow-up data, leaving the Maintenance Phase unexplored.

This study aims to investigate the effects of CDP, including both the Decongestion and Maintenance phases, on sleep quality and QoL in women with Stage II BCRL.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Bolu, Turkey (Türkiye), 14030
        • Recruiting
        • Bolu abant Izzet Baysal University
        • Contact:
      • Bolu, Turkey (Türkiye), 14030
        • Not yet recruiting
        • Bolu abant Izzet Baysal University
        • Contact:
        • Principal Investigator:
          • Elif DUYGU, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • inability to communicate or cooperate
  • acute deep vein thrombosis, arterial insufficiency in the upper extremity, systemic diseases that could cause edema other than lymphedema (e.g., renal failure, liver failure, heart failure)
  • use of sleep medications or antidepressants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group

This study is planned as a prospective quasi-experimental design (pre-test, intervention, post-test). The study will be conducted at the Women's Health and Lymphedema Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Abant İzzet Baysal University, Bolu, Turkey. All participants will provide written informed consent before participating in the study.

Participants The study aims to include a total of 31 patients who develop unilateral upper extremity lymphedema following breast cancer surgery. The inclusion criterion for lymphedema diagnosis will be a difference of more than 2 cm in circumferential measurements between both arms. Only individuals diagnosed with lymphedema by a physician will be included in the study.
Other: Physiotherapy and rehabilitation

Complex 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.

Other Names:
  • Complex Decongestive Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: Baseline, 4th week and 1 month follow-up
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).
Baseline, 4th week and 1 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Dielectric Constant
Time Frame: Baseline, 4th week, 1 month follow-up
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).
Baseline, 4th week, 1 month follow-up
Volumetric Measurement
Time Frame: Baseline, 4th week, 1 month follow-up
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).
Baseline, 4th week, 1 month follow-up
Quality of life assessment
Time Frame: Baseline, 4th week, 1 month follow-up
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).
Baseline, 4th week, 1 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAIBU-FTR-ED-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the Personal Data Protection Law, the data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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