Electronic patient-reported outcome-based weight management versus usual care during induction chemotherapy followed by concurrent chemoradiotherapy in nasopharyngeal carcinoma: A phase II randomized controlled trial.

Abstract

1503 Background: Nearly almost patients with nasopharyngeal carcinoma (NPC) experience weight loss (WL) and malnutrition during treatment. However, effective patients' weight management remains a challenge, as no standardized approach currently exists. This study aimed to evaluate the feasibility and efficacy of an electronic patient-reported outcome (ePRO) based weight management in mitigating WL and malnutrition in patients with locally advanced NPC (LA-NPC) receiving induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT). Methods: In this phase II randomized controlled trial, eligible patients aged 18 to 70 years with stage III-IVa (AJCC 8 th) NPC were randomly assigned in a 1:1 ratio to either ePRO-based weight management (ePRO group) or usual care (UC group). Body weight, NRS2002, PG-SGA, EORTC QLQ-C30 and hematological indicators were collected at six timepoints during treatment. Patients in ePRO group used the ePRO weight management system (ePRO-WMS). When predefined e-alert were triggered (e.g., WL > 5%), the MDT promptly communicated and responded with patients. Patients in UC group did not use the ePRO-WMS and had no e-alerts. The primary outcome was the proportion of patients experiencing WL > 10% at one month after completing CCRT (Post-1m). The secondary outcomes included WL > 10% and WL > 20% at the end of CCRT (W7-CCRT), as well as comparisons of NRS2002, PG-SGA, EORTC QLQ-C30, and hematological indicators. WL was compared using the χ² test, while other secondary outcomes were analyzed with linear mixed-effects models (ClinicalTrials.gov, NCT05834712). Results: From May 2022 to August 2023, 112 patients were enrolled in each group (76.8% male, 86.6% with ≥ junior high school education). 110 patients (UC group) and 109 patients (ePRO group) completed IC+CCRT. Among ePRO group, 107 patients successfully completed the ePRO-WMS, generating 561 e-alerts. Compared to UC group, ePRO group had significantly fewer patients with WL > 10% at Post-1m (37.5% vs. 57.1%, P = 0.003) and W7-CCRT (22.3% vs. 38.4%, P < 0.001). Additionally, ePRO group showed improved nutritional status (Retinol Binding Protein, 38.3 vs. 34.8, P = 0.011) and quality of life. Notably, reductions in inflammation (C-reactive protein, 10.4 vs. 15.9, P = 0.027) and immune suppression (CD4 + CD25 + regulatory T cells, 20.1 vs. 22.2, P = 0.034) were also observed. No significant differences were found between groups for acute adverse and progression-free survival (median follow-up time: 16 months). However, 2 cases of nasopharyngeal necrosis were observed in the UC group during follow-up. Conclusions: Compared to usual care, ePRO-based weight management in LA-NPC patients mitigated weight loss, alleviated inflammation, and significantly improved nutritional status and quality of life. Clinical trial information: NCT05834712 .