Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

Официальное название

Prevention-Related Lymphatic Response to Resistance Exercise in Breast Cancer Survivors at Risk of Breast Cancer-Related Lymphedema

Обзор

The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.

Подробное описание

Nowadays, research studies that confirm the safety and preventive effect of resistance or strength exercise in breast cancer-related lymphedema (BCRL) have been limited to the study of changes in variables related to the lymphatic response, such as bioimpedance spectroscopy , X-ray absorptiometry, perometry or water displacement after completion of a resistance exercise program (chronic effect).

To better understand the preventive effect of resistance exercise on the BCRL, in addition to studying the variables that are globally accepted and studied at a regional level such as the volume due to water displacement, variables that measure changes at a regional level related to body composition, such as such as echogenicity and ultrasound thickness, local tissue water and mechanical properties of tissues. Furthermore, this would allow us to detect possible changes in different body regions of the upper quadrant (upper extremity, but also breast or back), and not only taking global changes into account. On the other hand, the lymphatic response should be studied in the short term (acute effect), in the long term after an exercise program (chronic effect), as well as in the short term after the training period with possible adaptations to the lymphatic system that could explain the preventive effect.

Therefore, although there is a strong degree of scientific evidence to include therapeutic strength physical exercise as a preventive tool for LACM, the possible physiological mechanisms involved are unknown. The aim of the present project is to tudy the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using regional but also local variables related to the lymphatic response, as well as to study between changes in these variables, body composition at a local and regional level and volume changes produced by RTPE in breast cancer survivors at risk of suffering from BCRL

Вмешательства

• Другое Resistance Therapeutic Exercise
  Strength exercises will be aimed at large muscle groups, such as the shoulder, chest, back and also muscle groups of the lower extremities. In the initial 2 weeks, intervention will start with low intensities of around 55-65% of 1RM, which allows to perform around 15-20 repetitions. The first week there will be performed 2 series, while in the second week it will be 3 series. Moderate intensity in the 2nd week, corresponding to 65-75% of 1RM and allowing for around 8-12 repetitions. 3 series wi

Первичные конечные точки

• Changes in volume difference between extremities (%) [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]

Вторичные конечные точки (11)

• Changes in extracelular fluid (ECF) [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]
• Changes in Percentage Water Content (PWC) [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]
• Changes in Thickness of the dermis and subdermis [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]
• Changes in echogenicity of the dermis and subdermis [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]
• Changes in elastic properties of tissues. [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]
• Quality of life (QoL) [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]
• Active Range of Movement (AROM, degrees) [Срок оценки: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year]
• Grip strength (kg) [Срок оценки: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)]
• Perceived shoulder function (%) [Срок оценки: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)]
• Symptoms Related to Lymphedema [Срок оценки: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)]
• Fear-Avoidance [Срок оценки: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)]

Критерии участия

Критерии включения

• Women diagnosed with breast cancer
• Being of legal age
• Histologically confirmed primary Breast Cancer (I-IIIA) (without the presence of metastasis) with a diagnosis in the last year
• Unilateral involvement
• Surgery for the tumor at least 6 weeks before the start of the intervention
• WHO performance status of 0 (asymptomatic, complete and ambulatory activity)
• Correct understanding of Spanish
• Approval by signing the informed consent;
• Mus be considered at risk for developing LACM: 1) Have undergone surgery that includes axillary dissection; 2) Have received or are undergoing regional lymph node radiation; 3) BMI >30 kg/m2. . These patients are considered to have stage 0, subclinical or latent according to the International Society of Lymphology (ISL) , since they will not present signs or symptoms, but lymphatic transport will be altered by the treatments themselves

Критерии исключения

• Women already diagnosed with LACM in stage I, II or III according to the ISL or if they present an L-Dex ratio > 10 or a difference in volume equal to or greater than 10% between both extremities
• Suffer from or have been diagnosed with any other lymphatic-venous disease in the upper extremity, such as venous insufficiency, thrombosis or lipedema;
• Suffer from conditions that prevent resistance exercise of the upper body
• Participation in regular (>1 time/week) and intense exercises involving the upper extremity during the last month
• Suffer from heart disease
• Inability to complete questionnaires;
• A physical condition that prevents them from making hospital visits
• Taking any drug that may affect the lymphatic and circulatory system, such as diuretics or corticosteroids
• Women which presents some type of wound or infection on the skin.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Cristina Roldán Jiménez — Málaga

Публикации

• Roldán-Jiménez C. What are the physiologic effects of Resistance Exercise behind breast cancer-related lymphedema prevention? Medical Hypotheses Volume 171, February 2023, 111022. https://doi.org/10.1016/j.mehy.2023.111022
• Roldan-Jimenez C, Pajares B, Ruiz-Medina S, Trinidad-Fernandez M, Gonzalez-Sanchez M, Ribelles N, Garcia-Almeida JM, Rios-Lopez MJ, Alba E, Cuesta-Vargas AI. Design and implementation of a standard care programme of therapeutic exercise and education for breast cancer survivors. Support Care Cancer. 2022 Feb;30(2):1243-1251. doi: 10.1007/s00520-021-06470-9. Epub 2021 Aug 31. PMID 34463835
• Gutierrez-Sanchez D, Pajares-Hachero BI, Trinidad-Fernandez M, Escriche-Escuder A, Iglesias-Campos M, Bermejo-Perez MJ, Alba-Conejo E, Roldan-Jimenez C, Cuesta-Vargas A. The Benefits of a Therapeutic Exercise and Educational Intervention Program on Central Sensitization Symptoms and Pain-Related Fear Avoidance in Breast Cancer Survivors. Pain Manag Nurs. 2022 Aug;23(4):467-472. doi: 10.1016/j.pmn. PMID 35277360
• Roldan-Jimenez C, Martin-Martin J, Pajares B, Ribelles N, Alba E, Cuesta-Vargas AI. Factors associated with upper limb function in breast cancer survivors. PM R. 2023 Feb;15(2):151-156. doi: 10.1002/pmrj.12731. Epub 2021 Nov 23. PMID 34713595
• Escriche-Escuder A, Trinidad-Fernandez M, Pajares B, Iglesias-Campos M, Alba E, Cuesta-Vargas AI, Roldan-Jimenez C. Ultrasound use in metastatic breast cancer to measure body composition changes following an exercise intervention. Sci Rep. 2021 Apr 23;11(1):8858. doi: 10.1038/s41598-021-88375-5. PMID 33893370
• Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087. PMID 32589208
• Wang L, Shi YX, Wang TT, Chen KX, Shang SM. Breast cancer-related lymphoedema and resistance exercise: An evidence-based review of guidelines, consensus statements and systematic reviews. J Clin Nurs. 2023 May;32(9-10):2208-2227. doi: 10.1111/jocn.16437. Epub 2022 Jul 27. PMID 35894167

Идентификаторы

NCT: NCT06113627 · 10-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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