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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Sleep Quality [Срок оценки: Baseline, 4th week and 1 month follow-up]

Вторичные конечные точки (3)

• Quality of life assessment [Срок оценки: Baseline, 4th week, 1 month follow-up]
• Tissue Dielectric Constant [Срок оценки: Baseline, 4th week, 1 month follow-up]
• Volumetric Measurement [Срок оценки: Baseline, 4th week, 1 month follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 2 центра

• Bolu Abant Izzet Baysal University — Bolu
• Bolu Abant Izzet Baysal University — Bolu

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06697158 · BAIBU-FTR-ED-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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