A randomized, controlled trial to investigate cognitive behavioral therapy in prevention and treatment of acute oral mucositis in patients with locoregional advanced nasopharyngeal carcinoma undergoing chemoradiotherapy

Li-Li He; Shuai Xiao; Cui-Hong Jiang; Xiang-Wei Wu; Wen Liu; Chang-Gen Fan; Xu Ye; Qi Zhao; Wen-Qiong Wu; Yan-Xian Li; Hui Wang; Feng Liu

doi:10.3389/fonc.2023.1143401

A randomized, controlled trial to investigate cognitive behavioral therapy in prevention and treatment of acute oral mucositis in patients with locoregional advanced nasopharyngeal carcinoma undergoing chemoradiotherapy

Front Oncol. 2023 Jun 7:13:1143401. doi: 10.3389/fonc.2023.1143401. eCollection 2023.

Authors

Li-Li He¹, Shuai Xiao¹, Cui-Hong Jiang¹, Xiang-Wei Wu¹, Wen Liu¹, Chang-Gen Fan¹, Xu Ye¹, Qi Zhao¹, Wen-Qiong Wu¹, Yan-Xian Li¹, Hui Wang^{1

2}, Feng Liu¹

Affiliations

¹ Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.
² Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.

Abstract

Purpose: Oral mucositis is a common side effect of concurrent chemoradiotherapy (CCRT). This study aimed to determine whether cognitive behavioral therapy (CBT) could help prevent oral mucositis during chemoradiation therapy for locoregional advanced nasopharyngeal carcinoma (LA-NPC).

Methods and materials: Between July 15, 2020, and January 31, 2022, a randomized controlled phase II trial was conducted. Eligible patients (N=282, 18-70 years old) with pathologically diagnosed LA-NPC were randomly assigned to receive CBT or treatment as usual (TAU) during CCRT (computer-block randomization, 1:1). The primary endpoints were the incidence and latency of oral mucositis.

Results: The incidence of oral mucositis was significantly lower in the CBT group (84.8%; 95% confidence interval [CI], 78.7%-90.9%) than in the TAU group (98.6%; 95% CI, 96.6%-100%; P<0.001). The median latency period was 26 days and 15 days in the CBT and TAU groups, respectively (hazard ratio, 0.16; 95% CI, 0.12-0.22; P<0.001). CBT significantly reduced ≥ grade 3 oral mucositis (71.9% vs. 22.5%, P<0.001), dry mouth (10.8% vs. 3.7%, P=0.021), dysphagia (18% vs. 5.1%, P=0.001), and oral pain (10% vs. 3.6%, P=0.034) compared with TAU. Patients receiving CBT and TAU during CCRT had similar short-term response rates.

Conclusions: CBT reduced the occurrence, latency, and severity of oral mucositis in patients with LA-NPC during CCRT.

Keywords: acute oral mucositis; chemoradiotherapy; cognitive behavioral therapy (CBT); nasopharyngeal carcinoma; toxicities.

Grants and funding

This study was supported by grants from the Science and Technology Department of Hunan Province (No. S2021JJ30426), the Science and Technology Innovation Program of Hunan Province (No. 2021SK51114), the Health Commission of Hunan Province (No. C202309037955), National Natural Science Foundation of China (No. 82272758) and Supported By Hunan Cancer Hospital Climb Plan (No. ZX2020001). The funders had no role in the study design, data collection and analysis, decision to publish, or manuscript preparation.