A randomized, controlled, multicenter phase III clinical trial of Huo Xiang Zheng Qi oral liquid for the prevention and control of nausea and vomiting caused by multiday cisplatin-based regimen

BACKGROUND: Standardized chemotherapy-induced nausea and vomiting (CINV) prevention in HEC is critical, yet NK1RAs remain inaccessible for some patients due to cost and availability. Our prior study demonstrated HXZQ + 5HT3RAs + dexamethasone's superior efficacy; this phase III trial aimed to validate this regimen. METHOD: This multicenter, double-blind, randomized phase III trial (10 hospitals, Southwest China; March 2023-August 2024) assigned patients to group HX (HXZQ + 5HT3RA + dexamethasone) or group C (control). Primary endpoints: mean No CINV Days (NCDs) during the full cycle and complete control (CC) rate beyond the risk period. Secondary endpoints: safety, CC rate during the risk period, mean no nausea days and life function. RESULTS: A total of 166 patients were enrolled and 139 patients completed the study, 73 in group HX and 66 in group C. The mean NCDs was significantly better in group HX (17.92 ± 4.06) than that in group C (15.26 ± 5.91, P = .002). Group HX showed better NCDs in acute, delayed and the period beyond the risk phases than group C, with a higher CC rate of CINV beyond the risk phase (80.8% vs 60.6%, P = .009). The mean no nausea days in group HX was significantly better than that in group C (18.26 vs 15.45, P = .001). Group HX also showed a trend to better functional living index-emesis score, but only achieved the significance during the period beyond the risk phase. CONCLUSION: HXZQ in combination with a 5-HT3 receptor antagonist and dexamethasone is safe and feasible for preventing CINV due to 3-day cisplatin-containing HEC throughout the whole cycle.