Efficacy of a single dose of postoperative intravenous iron on erythropoietic recovery for Return to Intended Oncological Therapy in patients with head and neck cancer: A randomized controlled trial

Abstract Background and Aims: Perioperative anemia is a critical barrier to Return to Intended Oncological Therapy (RIOT) in head and neck cancer (HNC) patients. Surgery-induced systemic inflammation triggers a hepcidin surge, causing functional iron deficiency that limits erythropoiesis and delays recovery. We compared the efficacy of a single postoperative dose of intravenous versus oral iron therapy in elevating hemoglobin (Hb) concentrations at RIOT, typically occurring within the 4–6 week postsurgical window. Material and Methods: In this prospective, single-blinded, randomized trial, 80 HNC patients who underwent major resection and reconstruction surgery with postoperative day (POD) 1 Hb <10 g/dL were recruited. Group A received 200 mg daily oral ferrous fumarate via nasogastric tube. Group B received a single dose of 1000 mg IV ferric carboxymaltose on POD 1. Results: At 4–6 weeks, intergroup analysis showed no significant difference in absolute Hb levels (Group A: 10.91 ± 1.56 vs. Group B: 10.94 ± 1.05 g/dL; P = 0.907). However, intragroup analysis revealed a significant increase in Hb levels in both arms ( P < 0.001). The intergroup comparison of increase in Hb levels from POD 1 to 4–6 weeks recovery period showed that Group B achieved a significantly higher mean Hb increase compared to Group A (+2.07 vs. +1.52 g/dL; P = 0.002). Conclusions: A single postoperative dose of 1000 mg IV ferric carboxymaltose showed no superiority over oral iron in 4–6 week Hb levels or RIOT timing. IV iron achieved a significantly higher mean Hb increase compared to oral iron (+2.07 vs. +1.52 g/dL), but oral adherence was low.