A Randomized Controlled Trial of Cognitive Behavior Therapy to Reduce Oral Mucositis in Patients with Locoregional Advanced Nasopharyngeal Carcinoma Undergoing Chemoradiotherapy

Abstract

<h3>Purpose/Objective(s)</h3> Our previous study showed that cognitive behavioral therapy (CBT) significantly reduced the incidence of oral mucositis in patients with locoregional advanced nasopharyngeal carcinoma (NPC) undergoing chemoradiotherapy (Liu F, et al. Integr Cancer Ther. 2021;20:1-9), but it was limited by its retrospective nature. The purpose of this phase 2 randomized controlled trial was to evaluate the efficacy of cognitive behavioral therapy on reducing the occurrence and severity of oral mucositis in patients with locoregional advanced NPC undergoing chemoradiotherapy. <h3>Materials/Methods</h3> From July 2020 to June 2021, a total of 302 patients with diagnosis of stage III-IVA NPC (AJCC 8th) were randomly assigned (1:1) to receive CBT plus chemoradiotherapy (CBT group, n=151) or treatment as usual (TAU) plus chemoradiotherapy (TAU group or controlled group, n=151). Patients in both groups received induction chemotherapy (three cycles of gemcitabine/cisplatin or docetaxel/cisplatin/ 5-fluorouracil) followed by concurrent chemoradiotherapy (three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy). And all patients received education given at irregular intervals that included information about health, nutrition, and psychology. Patients in the CBT group received a series of six CBT sessions for 6 weeks during concurrent chemoradiotherapy. Weekly themes and main content of CBT sessions included introduction and establishment of a therapeutic relationship in the first week, understanding the relationships between thoughts, emotions, and behavior in the second week, cognitive restructuring from week 3 to week 5, and consolidating the experiences of dealing with emotional problems in the sixth week. The Primary end point was oral mucositis incidence. Treatment response, acute and late adverse events were evaluated. This trial is registered with chictr.org.cn, number ChiCTR2000034701. <h3>Results</h3> The incidence of oral mucositis was significantly lower in the CBT group (84.1%) compared with that in the TAU group (93.4%, P=0.011). Compared with the TAU, CBT significantly reduced oral mucositis severity scores recorded by investigators (25.0 [0.0–65.0] vs. 55.8 [0.0–88.0], <i>P</i><0.01) and patients (3.0 [0–10] vs. 6.0 [0–10], <i>P</i><0.01). Compared with the TAU group, the CBT group also showed a significantly lower incidence of Grade 3–4 fatigue (6.0% vs. 13.9% P=0.021), insomnia (5.3% vs. 14.6% P=0.007), anemia (0.0% vs. 5.3% P=0.012), and weight losing (0.0% vs. 4.0% P=0.039). The objective response rate (ORR) was 100% in both groups, and the complete response (CR) rate was similar in patients with CBT and with TAU (97.4% vs. 95.4%, P=0.539). <h3>Conclusion</h3> Cognitive behavioral therapy significantly reduced the occurrence and severity of oral mucositis in patients with locoregional advanced nasopharyngeal carcinoma during chemoradiotherapy treatment.