A two-phase study investigating the benefit of additional 0.5% cocaine mouthwash to institutional standard of care mucositis management

Abstract

Purpose Mucositis remains a challenging complication of radiotherapy or chemoradiotherapy (CRT) for head and neck cancer (HNC) patients. There is limited data on the safety or effectiveness of cocaine mouthwash (CMW) to treat mucositis. Methods This was single centre, prospective sequential cohort study in HNC patients undergoing CRT. Patients were allocated to the standard of care mucositis management (SOC arm) or SOC + 0.5% CMW (CMW arm). We assessed the benefit of CMW in the management of mucositis on patient reported quality of life (QoL) using the EORTC QLQ-C30 and H&N35 questionnaires at baseline, during CRT, at 1- and 3-months follow-up. Results 64 patients were enrolled in the SOC arm and 65 patients in the CMW arm. Baseline characteristics were similar between the arms. Most patients were male (80-89%) who received 70Gy of radiation (63-78%) with cisplatin (86-94%). Grade 2 and 3 mucositis were experienced in up to 51.7% and 28.8% patients respectively, but no meaningful differences were observed between the arms. Morbidity was high without significant differences observed between arms, with high hospitalisation rates (45.3-53.8%), need for enterostomy feeding (21.9-36.9%) and opioid analgesic prescription (≤56.5%). Weight at 3-month follow-up was significantly lower compared to baseline for both arms but was not significantly different between the arms. No significant differences were observed in patient reported QoL between the arms (adjusted and unadjusted), or when assessed using a 10-point clinically meaningful difference threshold (p>0.05). Conclusion Addition of CMW to SOC management did not demonstrate benefit or harm. CRT associated mucositis has significant morbidity.