Preoperative steroid for enhancing patients’ recovery after head and neck cancer surgery with free tissue transfer reconstruction: Phase III, placebo-controlled, randomized, double-blind study (J-SUPPORT 2022, PreSte-HN Study).

6072 Background: The enhanced recovery after surgery (ERAS) pathway integrates evidence-based protocols to optimize recovery during the perioperative period. It has recently been applied to head and neck cancer surgery with free tissue transfer reconstruction (HNS-FTR). While preoperative corticosteroid administration has shown benefits in reducing postoperative pain and nausea/vomiting in certain surgeries, its role in the ERAS pathway for HNS-FTR remains unclear. This study aimed to assess the impact of adding preoperative corticosteroid administration on the quality of postoperative recovery within the ERAS pathway for HNS-FTR. Methods: This phase III, placebo-controlled, randomized, double-blind trial included 180 patients undergoing HNS-FTR. Patients were randomly assigned (1:1) to receive either 8.0 mg of dexamethasone phosphate in 100 mL of saline or placebo (100 mL of saline) as a single intravenous dose preoperatively. All patients received standardized perioperative care under the multicenter ERAS pathway for HNS-FTR. The primary endpoint was the quality of postoperative recovery, assessed by the area under the curve (AUC) for the total scores of the Japanese version of the Quality of Recovery Score (QOR-40J) on postoperative days 2 and 4. Key secondary endpoints included the AUC of visual analog scale (VAS) scores for pain and nausea on postoperative days 1 to 3. Complications were analyzed using the Clavien-Dindo classification. Results: Data from 87 and 91 patients in the dexamethasone and placebo groups, respectively, were evaluated. ERAS pathway completion rates were 97.7% and 97.8% for the dexamethasone and placebo groups, respectively. The estimated AUC for QOR-40J total scores on postoperative days 2 and 4 was 295.7 in the dexamethasone group and 299.8 in the placebo group, with no significant difference (p = 0.665). Similarly, no significant differences were observed in VAS scores for pain (p = 0.829) and nausea (p = 0.649). While there were no significant differences in complications of Grade 2 or higher (p = 0.584) or wound-related complications (p = 0.938), a significant difference was found in postoperative bleeding, with no cases observed in the placebo group (p = 0.039). Conclusions: Preoperative corticosteroid administration in the ERAS pathway for HNS-FTR did not yield clinically significant benefits. Ensuring the successful implementation of the ERAS pathway is crucial. Clinical trial information: jRCTs031210593 .