Abstract

Abstract Introduction Anaemia and fatigue are highly prevalent in advanced cancer. Intravenous iron (IVI) has shown promise as an effective treatment for anaemia across a number of conditions. For the first time, we explore the impact of IVI on physical activity and quality of life (QoL) in advanced, inoperable cancer. Methods We randomised anaemic, fatigued patients with advanced solid cancers to receive either IVI (iron isomaltoside) or placebo (0.9% NaCl) in a double-blind design. Activity was assessed using a pedometer (Fitbit Flex 2) for 8 days pre- infusion and at 4 and 8 weeks post-infusion. The minimum clinically important difference (MCID) was defined as 600 daily steps. Three validated QoL questionnaires were completed at the same timepoints. Results 34 patients were recruited over 15 months (17 IVI, 17 placebo). Haemoglobin was higher with IVI at 4 weeks (MD 7.3g/L, P=0.047) and 8 weeks (MD 4.3g/L, P=0.13). At 8 weeks the mean difference in daily steps was 1707 (1142) steps (IVI +318 [1195] from baseline; placebo -1658 [2846]). On QoL measures global health (MD 15.8, P=0.027) and social functioning (MD 14.9, P=0.019) improved with IVI at 4 weeks. Fatigue scores exceeded the intergroup MCID for IVI at both follow up timepoints (week 4 MD 3.38 [-14.94–8.18], P=0.548], week 8 MD 3.49 [-17.52–10.53], P=0.609). Conclusion IVI maintained physical activity and improved fatigue specific QoL. Placebo was associated with a significant decline activity and fatigue specific QoL. IVI may delay the functional decline experienced with advanced cancer. Take-home message Intravenous iron led to clinically meaningful improvements in quality of life and physical activity in anaemic patients with advanced cancer.

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