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Background: Subjects with head and neck cancer (HNC) often experience post-treatment side effects, particularly radiation-induced oral mucositis (RIOM). This study aimed to explore the association of Chinese herbal medicine use with the sequent risk of RIOM among them., Methods: This cohort study used a nationwide health insurance database to identify subjects newly diagnosed with HNC, aged 20 to 60 years, who received treatment between 2000 and 2007. Among them, a total of 561 cases received CHM after HNC onset (CHM users); the remaining 2395 cases were non-CHM users. All patients were followed to the end of 2012 to identify any treatment for RIOM as the end point. Cox proportional hazards regression was used to compute the adjusted hazard ratio (aHR) of RIOM by CHM use., Results: During the follow-up period, 183 CHM users and 989 non-CHM users developed RIOM at incidence rates of 40.98 and 57.91 per 1000 person-years, respectively. CHM users had a lower RIOM risk than the non-CHM users (aHR: 0.68; 95% Confidence Interval: 0.58-0.80). The most potent effect was observed in those taking CHM for more than 1 year. Use of Baizhi, Danshen, Shao-Yao-Gan-Cao-Tang, Gan-Lu-Yin, Huangqin, Shu-Jing-Huo-Xue-Tang, and Xin-Yi-Qing-Fei-Tang, was significantly related to a lower risk of RIOM., Conclusion: Findings of this study indicated that adding CHM to conventional clinical care could be helpful in protecting those with HNC against the onset of RIOM. Further clinical and mechanistic studies are warranted.

Purpose: Deleterious oral mucositis (OM) develops during radiotherapy (RT) or chemoradiotherapy for head-and-neck cancer (HNC) patients. There are currently no effective cytoprotective treatments for OM without a potential risk of tumor protection. This randomized, double-blind, placebo-controlled pilot study aimed to determine the therapeutic safety and efficacy of phenylbutyrate (an antitumor histone deacetylase inhibitor and chemical chaperone) 5% mouthwash for treating OM caused by cancer therapy., Methods and Materials: Between September 2005 and June 2006, 36 HNC patients were randomized to standard oral care plus 5 mL of either phenylbutyrate 5% mouthwash (n = 17) or placebo (mouthwash vehicle, n = 19) taken four times daily (swish and spit). Treatment began when mild mucositis (Radiation Therapy Oncology Group Grade 1) occurred, and ended 4 weeks after RT completion. Safety and efficacy were based on adverse events, physical examination, laboratory determinations, vital signs, Oral Mucosa Assessment Scale (OMAS) and World Health Organization scores, the ability to eat, body weight change, local control, and survival., Results: We found no severe drug-related side effect. At RT doses of 5500-7500 cGy, phenylbutyrate significantly mitigated the severity of mucositis compared with placebo, based on both the WHO score (severity ≥ 3; p = 0.0262) and the OMAS scale (ulceration score ≥ 2; p = 0.0049). The Kaplan-Meier estimates for 2- and 3-year local control, and overall survival were 100% and 80.8%, and 78.6% and 64.3%, respectively, in the phenylbutyrate group and 74.2% and 74.2%, and 57.4% and 50.2%, respectively, in the placebo group., Conclusions: This pilot trial suggested that phenylbutyrate mouthwash significantly decreased the impact of OM in HNC patients receiving RT or chemoradiotherapy and did not confront the tumor control. Larger Phase II randomized trials are needed to confirm these results., (Copyright © 2012 Elsevier Inc. All rights reserved.)