Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

Trial Title: Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

NCT ID: NCT06113627

Condition: Breast Cancer Lymphedema
Survivorship
Lymphedema of Upper Limb

Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema

Conditions: Keywords:
Breast Cancer
Lymphedema, Early-Onset
Breast Cancer Lymphedema
Exercise Therapy
Exercise Training
Acute Exercise
Exercise Movement Techniques
Physiotherapy (Techniques)

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized Controlled Trial

Primary purpose: Prevention

Masking: Double (Investigator, Outcomes Assessor)

Masking description: Blinding of the researchers in charge of the evaluations and data analysis will be implemented, so that they are unaware of the assignment of each patient to the groups. It is not possible to blind participants and the physiotherapist (care provider) due to the very nature of the intervention

Intervention:

Intervention type: Other
Intervention name: Resistance Therapeutic Exercise
Description: 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 will be maintained throughout this period of time.In addition to the progressive change in intensity, throughout the intervention the load will be increased by 5-10% when the patient performs the exercise too easily or when they can perform more repetitions than estimated. Rest between sets will be 2-3 minutes.
Arm group label: Exercise group

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

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cristina Roldán Jiménez

Address:
City: Málaga
Country: Spain

Contact:
Last name: Cristina Roldán-Jiménez, PhD

Start date: August 2024

Completion date: January 15, 2027

Lead sponsor:
Agency: University of Malaga
Agency class: Other

Source: University of Malaga

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06113627