Combined Exercise Effects in Breast Cancer-related Lymphedema

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFaculdade de Motricidade Humana

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

Treatment groups

58 Participants
are divided into 2 treatment groups