BACKGROUND/OBJECTIVES: Breast cancer-related lymphedema (BCRL) is more prevalent and severe in women with overweight or obesity. This study evaluated the effect of a comprehensive lifestyle intervention-comprising supervised exercise, a hypocaloric Mediterranean diet, and optional meal replacement-on lymphedema outcomes in this population. METHODS: In this pilot randomized controlled trial, 112 women with BCRL and BMI 25 to 40 kg/m2 were assigned to an intervention group-receiving supervised resistance and aerobic training, dietary counseling, and optional high-protein meal replacement-or to a control group with standard advice. The primary outcome was change in affected limb volume at 3 and 6 months. Secondary outcomes included morphofunctional parameters, muscle strength, dietary intake, and serum levels of cytokines (IL-1beta, IL-6, IL-10, and TNF-alpha). Analyses also explored outcomes according to whether participants achieved >= 5% weight loss. RESULTS: Ninety-four participants completed the trial (intervention n = 43, control n = 51). At 6 months, women who achieved >= 5% weight loss had greater reductions in affected limb volume (-664.9 +/- 362.1 mLversus -395.6 +/- 596.9 mL). The intervention group showed significantly greater improvements in BMI (-1.14 +/- 1.22 kg/m2), waist circumference (-3.59 +/- 4.6 cm), triceps skinfold (-4.61 +/- 3.02 mm), fat mass (-2.38 +/- 2.75 kg), extracellular water (-0.58 +/- 0.85 L), and quadriceps strength (+7.1 +/- 9.7 kg). No significant changes were observed in circulating cytokines. CONCLUSIONS: In this pilot randomized controlled trial, a structured dietary and exercise intervention improved morphofunctional outcomes in overweight women with BCRL. Weight loss of >= 5% emerged as a potentially relevant therapeutic target that may inform the design of future studies aimed at optimizing lymphedema management.

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