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

NCT06697158 | Recruiting

• 1 other identifier: BAIBU-FTR-ED-003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Breast Cancer Related Lymphedema

Keywords

Breast Cancer-Related Lymphedema; Physiotherapy and Rehabilitation; Sleep Quality; Local Tissue Fluid; Quality of Life

Outcome Measures

Primary Outcomes (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).

  Baseline, 4th week and 1 month follow-up

Secondary Outcomes (3)

• Quality of life assessment

  Baseline, 4th week, 1 month follow-up

• Tissue Dielectric Constant

  Baseline, 4th week, 1 month follow-up

• Volumetric Measurement

  Baseline, 4th week, 1 month follow-up

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

Physiotherapy and rehabilitation OTHER

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.

Also known as: Complex Decongestive Physiotherapy

Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (2)

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

NOT YET RECRUITING

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

RECRUITING

Related Publications (22)

• 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.

  PMID: 35997891 BACKGROUND

• 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.

  PMID: 36447505 BACKGROUND

• 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.

  PMID: 17539462 BACKGROUND

• 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.

  PMID: 32730184 BACKGROUND

• 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.

  PMID: 38477155 BACKGROUND

• 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.

  PMID: 33449865 BACKGROUND

• 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.

  PMID: 32803533 BACKGROUND

• 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.

  PMID: 15095073 BACKGROUND

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

  PMID: 17853619 BACKGROUND

• 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.

  PMID: 18540873 BACKGROUND

• 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.

  PMID: 28894851 BACKGROUND

• 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.

  PMID: 9720850 BACKGROUND

• 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.

  PMID: 38806742 BACKGROUND

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

  PMID: 30248726 BACKGROUND

• 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.

  PMID: 38862116 BACKGROUND

• Tamam N, Al-Mugren KS, Alrebdi HI, Sulieman A, Abdelbasset WK. Evaluating the Quality of Life and Sleep Quality in Saudi Women with Breast Cancer-Related Lymphedema: A Cross-Sectional Correlational Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211046192. doi: 10.1177/15347354211046192.

  PMID: 34541909 BACKGROUND

• Mete Civelek G, Akinci MG, Dalyan M. Evaluation of Sleep Quality, Depression, and Quality of Life in Patients with Breast Cancer Related Lymphedema. Lymphat Res Biol. 2023 Jun;21(3):289-295. doi: 10.1089/lrb.2022.0031. Epub 2022 Sep 29.

  PMID: 36178954 BACKGROUND

• Kayiran O, De La Cruz C, Tane K, Soran A. Lymphedema: From diagnosis to treatment. Turk J Surg. 2017 Jun 1;33(2):51-57. doi: 10.5152/turkjsurg.2017.3870. eCollection 2017.

  PMID: 28740950 BACKGROUND

• Duygu-Yildiz E, Bakar Y, Hizal M. The effect of complex decongestive physiotherapy applied with different compression pressures on skin and subcutaneous tissue thickness in individuals with breast cancer-related lymphedema: a double-blinded randomized comparison trial. Support Care Cancer. 2023 Jun 7;31(7):383. doi: 10.1007/s00520-023-07843-y.

  PMID: 37285046 BACKGROUND

• DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.

  PMID: 23540561 BACKGROUND

• Executive Committee of the International Society of Lymphology. The Diagnosis and Treatment of Peripheral Lymphedema: 2023 Consensus Document of The International Society of Lymphology. Lymphology. 2023;56(4):133-151.

  PMID: 39207406 BACKGROUND

• Sharifi N, Ahmad S. Breast cancer-related lymphedema: A critical review on recent progress. Surg Oncol. 2024 Oct;56:102124. doi: 10.1016/j.suronc.2024.102124. Epub 2024 Aug 23.

  PMID: 39208532 BACKGROUND

Related Links

• breast cancer statistics

MeSH Terms

Conditions

Breast Cancer Lymphedema; Sleep Initiation and Maintenance Disorders

Interventions

Physical Therapy Modalities; Rehabilitation

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Elif DUYGU, PhD

CONTACT

+905052539010; elifduygu@ibu.edu.tr

Zeynep DURU, MSc

CONTACT

+905344095717; zeyneppdduru@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT PhD

Model Details: Quasi-experimental design

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)