Effects of Aerobic Exercise Training in Anemic Cancer Patients Receiving Darbepoetin Alfa: A Randomized Controlled Trial

Background. Anemia in patients with solid tumors is a common problem that is associated with impaired exercise capacity, increased fatigue, and lower quality of life (QoL). Erythropoiesis‐stimulating agents (ESAs) have been shown to improve these outcomes; however, it is unknown if additional benefits can be achieved with aerobic exercise training. Methods. We conducted a single‐center, prospective, randomized, controlled trial in 55 mild‐to‐moderately anemic patients with solid tumors. Patients were randomized to either darbepoetin alfa alone (DAL, n = 29) or darbepoetin alfa plus aerobic exercise training (DEX; n = 26). The DEX group performed aerobic exercise training three times per week at 60%–100% of baseline exercise capacity for 12 weeks. The primary endpoint was QoL assessed by the Functional Assessment of Cancer Therapy–Anemia scale. Secondary endpoints were fatigue, cardiorespiratory fitness (VO2peak), hemoglobin (Hb) response, and darbepoetin alfa dosing. Results. Intention‐to‐treat analyses indicated significant improvements in QoL and fatigue in both groups over time but there were no between‐group differences. The DEX group had a significantly greater VO2peak than the DAL group (mean group difference, +3.0 ml/kg per minute; 95% confidence interval, 1.2–4.7; p = .001) and there were borderline significant differences in favor of the DEX group for Hb response and darbepoetin alfa dosing. Conclusions. Aerobic exercise training did not improve QoL or fatigue beyond the established benefits of DAL but it did result in favorable improvements in exercise capacity and a more rapid Hb response with lower dosing requirements. Our results may be useful to clinicians despite the more recent restrictions on the indications for ESAs. The study reports results from the Exercise Training and Anemia trial comparing the effects of darbepoetin alfa alone with those of darbepoetin alfa plus aerobic exercise training on quality of life, fatigue, cardiorespiratory fitness, hemoglobin response, and drug dosing requirement in mild‐to‐moderately anemic cancer patients.