Clinical trial NCT06113627: Lymphatic Response to Resistance Exercise in Breast Cancer Survivors
Official title: Prevention-Related Lymphatic Response to Resistance Exercise in Breast Cancer Survivors at Risk of Breast Cancer-Related Lymphedema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Lymphedema
Survivorship
Lymphedema of Upper Limb
Keywords: Breast Cancer
Lymphedema, Early-Onset
Breast Cancer Lymphedema
Exercise Therapy
Exercise Training
Acute Exercise
Exercise Movement Techniques
Physiotherapy (Techniques)
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in volume difference between extremities (%)
timeFrame: 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
Secondary outcomes:
measure: Changes in extracelular fluid (ECF)
timeFrame: 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
measure: Changes in Percentage Water Content (PWC)
timeFrame: 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
measure: Changes in Thickness of the dermis and subdermis
timeFrame: 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
measure: Changes in echogenicity of the dermis and subdermis
timeFrame: 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
measure: Changes in elastic properties of tissues.
timeFrame: 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
measure: Quality of life (QoL)
timeFrame: 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
measure: Active Range of Movement (AROM, degrees)
timeFrame: 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
measure: Grip strength (kg)
timeFrame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
measure: Perceived shoulder function (%)
timeFrame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
measure: Symptoms Related to Lymphedema
timeFrame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
measure: Fear-Avoidance
timeFrame: Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up)
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Cristina Roldán Jiménez
Study officials:
References:
citation: 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
citation: 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.
citation: 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.2022.01.003. Epub 2022 Mar 9.
citation: 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.
citation: 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.
citation: 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.
citation: 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.