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Breast Cancer Related LymphedemaNCT06697158

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

A study testing Physiotherapy and rehabilitation in people with Breast Cancer Related Lymphedema, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Breast Cancer Related Lymphedema
What is being tested?
Physiotherapy and rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Jan 2024to 1 Mar 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elif DUYGU, PhD contact

+905052539010

elifduygu@ibu.edu.tr

Zeynep DURU, MSc contact

+905344095717

zeyneppdduru@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • Bolu Abant Izzet Baysal University

    Bolu, 14030

    Ramazan KURUL, PhD, +905436414731, ramazankurul@ibu.edu.tr

    Elif DUYGU, PhD

    Not yet recruiting
  • Bolu Abant Izzet Baysal University

    Bolu, 14030

    Elif Duygu Yildiz, Assist Prof., 05052529010, elifduygu@ibu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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).

Read more

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.

Read the 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.

Being tested
Physiotherapy and rehabilitation
Keywords
Breast Cancer-Related Lymphedema, Physiotherapy and Rehabilitation, Sleep Quality, Local Tissue Fluid, Quality of Life
Medical subject headings
Breast Cancer Lymphedema, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physiotherapy and rehabilitationOther

    Also called Complex Decongestive Physiotherapy

    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.

Study groups in NCT06697158
Study groupRoleWhat they receive
Treatment GroupExperimentalThis 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.
Receives: Other: Physiotherapy and rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, 4th week and 1 month follow-up

Secondary outcomes (3)
  1. 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).

    Measured: Baseline, 4th week, 1 month follow-up

  2. 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).

    Measured: Baseline, 4th week, 1 month follow-up

  3. 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).

    Measured: Baseline, 4th week, 1 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start1 Jan 2024
  3. Primary completion12 Dec 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Quasi-experimental design
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697158
Sponsor's protocol ID
BAIBU-FTR-ED-003
Status last verified
Mar 2026
First submitted
18 Nov 2024
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the Personal Data Protection Law, the data will not be shared.

Publications

  • Konishi T, Tanabe M, Michihata N, Matsui H, Nishioka K, Fushimi K, Seto Y, Yasunaga H. Risk factors for arm lymphedema following breast cancer surgery: a Japanese nationwide database study of 84,022 patients. Breast Cancer. 2023 Jan;30(1):36-45. doi: 10.1007/s12282-022-01395-5. Epub 2022 Aug 23.

    PubMed 35997891
  • Janavlekar MG, Verma CV, Mistry HM. Effect of Complete Decongestive Therapy on Lymphoedema, Sleep Quality and Quality of Life in Metastatic Breast Cancer Patient - A Case Study. Indian J Palliat Care. 2022 Oct-Dec;28(4):439-442. doi: 10.25259/IJPC_78_2022. Epub 2022 Aug 25.

    PubMed 36447505
  • Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.

    PubMed 17539462
  • Naoum GE, Roberts S, Brunelle CL, Shui AM, Salama L, Daniell K, Gillespie T, Bucci L, Smith BL, Ho AY, Taghian AG. Quantifying the Impact of Axillary Surgery and Nodal Irradiation on Breast Cancer-Related Lymphedema and Local Tumor Control: Long-Term Results From a Prospective Screening Trial. J Clin Oncol. 2020 Oct 10;38(29):3430-3438. doi: 10.1200/JCO.20.00459. Epub 2020 Jul 30.

    PubMed 32730184
  • Ahn HR, Jeong HE, Jeong C, Kang SY, Jung SH, Youn HJ, Kim JS. Incidence and risk factors of breast cancer-related lymphedema in Korea: a nationwide retrospective cohort study. Int J Surg. 2024 Jun 1;110(6):3518-3526. doi: 10.1097/JS9.0000000000001278.

    PubMed 38477155
  • Corum M, Basoglu C, Korkmaz MD, Yildirim MA, Ones K. Effectiveness of Combined Complex Decongestive Therapy and Resistance Exercises in the Treatment of Lymphedema Associated with Breast Cancer and the Effect of Pain on Treatment Response. Lymphat Res Biol. 2021 Aug;19(4):383-390. doi: 10.1089/lrb.2020.0099. Epub 2021 Jan 15.

    PubMed 33449865
  • Thompson B, Gaitatzis K, Janse de Jonge X, Blackwell R, Koelmeyer LA. Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature. J Cancer Surviv. 2021 Apr;15(2):244-258. doi: 10.1007/s11764-020-00928-1. Epub 2020 Aug 15.

    PubMed 32803533
  • Kligman L, Wong RK, Johnston M, Laetsch NS. The treatment of lymphedema related to breast cancer: a systematic review and evidence summary. Support Care Cancer. 2004 Jun;12(6):421-31. doi: 10.1007/s00520-004-0627-0. Epub 2004 Apr 17.

    PubMed 15095073
  • Mayrovitz HN. Assessing local tissue edema in postmastectomy lymphedema. Lymphology. 2007 Jun;40(2):87-94.

    PubMed 17853619
  • Mayrovitz HN, Davey S, Shapiro E. Local tissue water assessed by tissue dielectric constant: anatomical site and depth dependence in women prior to breast cancer treatment-related surgery. Clin Physiol Funct Imaging. 2008 Sep;28(5):337-42. doi: 10.1111/j.1475-097X.2008.00814.x. Epub 2008 Jun 5.

    PubMed 18540873
  • Bakar Y, Tugral A, Ozdemir O, Duygu E, Uyeturk U. Translation and Validation of the Turkish Version of Lymphedema Quality of Life Tool (LYMQOL) in Patients with Breast Cancer Related Lymphedema. Eur J Breast Health. 2017 Jul 1;13(3):123-128. doi: 10.5152/ejbh.2017.3522. eCollection 2017 Jul.

    PubMed 28894851
  • Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res. 1998 Jul;45(1):5-13. doi: 10.1016/s0022-3999(97)00298-5.

    PubMed 9720850
  • Kavak SK, Kavak EE. Fatigue and sleep quality improvement through complete decongestive therapy in postmastectomy lymphedema: An investigative analysis. Support Care Cancer. 2024 May 29;32(6):392. doi: 10.1007/s00520-024-08590-4.

    PubMed 38806742
  • Tzani I, Tsichlaki M, Zerva E, Papathanasiou G, Dimakakos E. Physiotherapeutic rehabilitation of lymphedema: state-of-the-art. Lymphology. 2018;51(1):1-12.

    PubMed 30248726
  • Sahbaz-Pirincci C, Cihan E, Duzlu-Ozturk U, Borman P, Dalyan M. Comparing complex decongestive therapy in patients with lymphedema of different causes by measuring: extremity volume, quality of life, and functionality. Cir Cir. 2024;92(3):354-361. doi: 10.24875/CIRU.23000330.

    PubMed 38862116

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