About this trial
Breast cancer-related lymphedema (BCRL) is a common and debilitating condition that affects quality of life, mobility, and well-being. While exercise was once thought to worsen symptoms, current evidence suggests it may improve lymphatic function and symptom management. The LymFit project will test a 12-week combined exercise program (aerobic + resistance) in breast cancer survivors with BCRL compared to usual care.
This investigation aims to unravel the effects of a combined exercise program on BCRL management. A 12-week randomized controlled trial will be conducted with two arms: a combined exercise intervention (strength + aerobic training) and a control group. The LymFit project primarily aims to assess the effects of 12 weeks of combined exercise on L-Dex in BCRL patients. Secondary objectives include evaluating exercise's effects on i) ECW:ICW ratio (dilution techniques); ii) Body composition (dual-energy X-ray absorptiometry), handgrip strength (dynamometry), cardiorespiratory fitness, quality of life, arm disability, anxiety, depression (questionnaires), and inflammatory profile (blood analysis). The project also examines acute exercise (pre- to post-session) responses on iii) Lymphedema (L-Dex) and iv) Fluid shifts (ultrasound muscle thickness + PV measurement). By integrating clinical outcomes with mechanistic evaluations, this randomized controlled trial seeks to generate evidence-based recommendations for exercise in BCRL management and improve understanding of lymphatic fluid dynamics in this population.
Eligibility criteria
Qualifiers
Aged 18 years or older;
Undergone breast cancer surgery with removal of at least one lymph node;
Clinical diagnosis of stable unilateral breast cancer-related lymphedema;
Willing and able to engage in exercise;
Disqualifiers
Unstable lymphedema (therapist-delivered treatment and more than one arm infection requiring antibiotics in the past 3 months);
Undergoing radiotherapy or chemotherapy by infusion for breast cancer;
Bilateral lymphedema;
Primary lymphedema;
Trial design
Treatments tested in this trial
- Exercise
- Educational Sessions