A randomized, controlled phase II trial of maxillofacial and oral massage in attenuating severe radiotherapy-induced oral mucositis and lipid metabolite changes in nasopharyngeal carcinoma.

PURPOSE

This randomized controlled phase II study investigated the efficacy, safety and underlying mechanism of maxillofacial and oral massage (MOM) in nasopharyngeal carcinoma (NPC) patients receiving intensity-modulated radiotherapy.

METHODS

A total of 158 NPC patients were randomly assigned 1:1 to routine oral care and medication (the control group) or that with additional MOM (the treatment group). The primary endpoint was the incidence of severe radiotherapy-induced oral mucositis (SRTOM). In addition, the time of initiation and duration of RTOM and SRTOM, adverse events, dynamic changes of lipid metabolites in peripheral blood were analyzed.

RESULTS

Seventy-six patients in the treatment group and seventy-nine in the control group completed the trial. The incidence of SRTOM in the treatment group was lower than the control (26.3% vs. 46.8%, P = 0.008). The median initiation time to RTOM and SRTOM was significantly longer in the treatment group than the control (RTOM:12 vs 10 days, hazard ratio [HR] 0.52, P < 0.001; SRTOM: 28.5 vs 19 days, HR 0.5579, P = 0.002). While the median duration time of RTOM and SRTOM in the treatment group was shorter (RTOM: 20.7 vs 24.7 days, P = 0.001; SRTOM: 8.05 vs 13.08 days, P < 0.001). Only 1.3% of patients obtained grade 3 or higher adverse events during MOM. The anti-inflammatory lipids increased significantly after MOM, especially with 10.6 Gy or higher.

CONCLUSION

MOM significantly attenuated the incidence of SRTOM in NPC patients. The adverse events of MOM were slight and tolerant. MOM enhanced anti-inflammatory lipid metabolites, which might be an underlying mechanism.