Physiotherapy Program Impact on Breast Cancer-Related Lymphedema

European University Miguel de Cervantes21 enrolled

Overview

Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection and regional lymph node radiation. The main objective of the present clinical trial is to determine the effectiveness of moderate-high intensity strength training in combination with an aerobic exercise protocol and the application of cohesive compression bandaging in subjects with or at risk for BCRL and to analyze the acute responses of the molecular, functional and clinical profile of patients with BCRL or at risk after two sessions of intervention. To compare proteomic analysis of patients or at risk with healthy controls and to assess the adaptations produced after 12 weeks of exercise intervention and over a 12-week post-intervention period in patients with BCRL or at risk.

Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection andregional lymph node radiation. Clinically, it can cause pain, swelling and a decrease in the functionality of those patients who suffer from it. Moderate-high intensity strength exercise, in combination with aerobic exercise and a cohesive compressive bandage, could minimize the associated symptomatology and clinical symptoms, as well as improve various biological parameters related to tumor progression and increase the functionality of patients. Likewise, the study of the long-term effects of the treatment will make it possible to determine the chronic adaptations generated by exercise. The intervention will consist of concurrent training (strength and aerobic exercise) for all patients, whether they have BCRL or are at risk. Also, patients with BCRL will have cohesive bandaging applied at the end of the exercise session. The main objective of this study is to determine the benefits that moderate-high intensity strength training, in combination with an aerobic exercise protocol and, together with the application of a compressive bandage, generates on patients suffering from BCRL or at risk of suffering it. Through this investigation, we seek to analyze the impact of the intervention on various clinical, functional, and molecular factors. Likewise, healthy controls participants will participate in two exercise interventions and functional and molecular adaptations will be analyzed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

12-week supervised exerciseOTHER

During the study period (1 week for acute effects, 12 weeks for chronic effects), there will be 8 sessions per month, lasting 40-60 minutes each, with 2 sessions per week on alternate days, totaling 24 sessions. Each session includes: (1) warm-up (mobility exercises); (2) training: 5-min warm-up, followed by 15-min moderate-to-high intensity circuit of 7 functional global exercises with 10 reps each at a perceived exertion effort (RPE) of 5-7 on a scale of 1 to 10; (3) Aerobic exercise: starting at 15 mins, increasing by 5 mins biweekly to 30 mins by week 7; (4) Cool-down (general mobility); (5) Application of cohesive compressive bandage on the affected upper limb, worn for 2 hours post-session, removed at home. Participants may add a cotton bandage and finger bandage if needed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Breast cancer survivors who have completed treatment (chemotherapy, surgery, and/or radiotherapy) at least 6 months prior to randomization for the trial. * Patients diagnosed with unilateral stage I or II BCRL as established by the International Society of Lymphology Congress Working Group in 2020, or patients at risk of developing unilateral BCRL (who have received radiotherapy in the axillary region/radical mastectomy/modified radical mastectomy and lymph node dissection/breast surgery and sentinel lymph node biopsy). * Age between 18 and 65 years. * Voluntary participation in the study and informed consent. Exclusion Criteria: * Recent surgery (\<3 months) or planned surgery during the study period. * Patients with cognitive impairment. * Patients with bilateral lymphedema. * Health problems or illnesses that prevent them from participating in the intervention. * Other serious conditions that may affect their HRQOL (Health-Related Quality of Life).

Outcomes

Primary Outcomes

Molecular variables: proteome.

Venous blood samples are collected from the antecubital vein and kept at 4°C until preparation to avoid clotting and minimise protein degradation. Samples are centrifuged at 1500 g for 10 minutes at 4°C. Subsequently, the plasma is centrifuged at 2500g for 15 minutes at 4°C. Samples shall are stored at -80°C for subsequent analysis and only one freeze-thaw cycle shall be allowed. All samples shall are prepared within 1 hour of sample collection and show no signs of haemolysis. Likewise, a tear sample (5-15 µl) is taken from each eye, using a microcapillary for each eye. The sample is taken non-traumatically from the outer third of the tear meniscus. Samples are split and used both for cytokine analysis using a Luminex and frozen at -80°C for analysis. The protein concentration will be analyzed.