Background & objective: Oropharyngeal mucositis is the most common acute non-hematology toxicity in nasopharyngeal carcinoma (NPC) treated with radiotherapy, especially in the concomitant chemoradiotherapy of local advanced NPC patients. This study was designed to observe the effect of traditional Chinese medicine against acute oropharyngeal mucositis from chemoradiotherapy in patients with local advanced NPC.
Methods: A total of 101 patients in stage III- IVa (Fuzhou 1992) were enrolled into this prospective randomized clinical trial. The cases were divided into treatment group (52 cases) and control group (49 cases). The median doses were 70.31+/-1.21 Gy for the treatment group and 70.78+/-1.95 Gy for the control group, respectively. Chemotherapy was concomitant with radiotherapy [single agent cisplatin (DDP,30 mg/m(2)) 6 times from first to sixth week of radiotherapy duration]. The patients of treatment group took 5-8 times of Chinese medicine daily and those of control group took 5-8 times of Dobell's solution daily.The observation indices included the degree of oropharyngeal and hematological toxicity, radiotherapy duration, and curative effect.
Results: (1)Oropharyngeal toxicity: there was no 0 degree oropharyngeal toxicity in both groups, I degree toxicity in 29 cases (55.77%) and 2 cases (4.08%), II degree toxicity in 18 cases (34.62%) and 17 cases (30.69%), III degree toxicity in 5 cases (9.62%) and 22 cases (44.89%), IV degree toxicity in 0 case (0%) and 8 cases (16.33%); there was statistical significance of difference between the two groups (P=0.000). (2)Hematological toxicity: there was no IV degree hematological toxicity in both groups. WBC toxicity (Z=-0.604,P=0.546), neutrophilic granulocyte toxicity (Z=-0.226,P=0.821), and platelet toxicity (Z=-0.099,P=0.922) were compared; there was no statistic significance of difference (P >0.05); (3)Radiotherapy duration: The radiotherapy duration of two groups were 49.79+/-1.83 days and 51.00+/-4.46 days; there was no statistic significance of difference (P=0.082). (4)Curative effects: The curative effects of two groups were:complete remission (CR) 76.92% (40/52) and 69.39% (34/49), partial remission (PR) 23.08% (12/52) and 30.61% (15/49); there was no statistical significance of difference (P=0.392).
Conclusion: Chinese medicine was effective in reducing acute oropharyngeal toxicity resulting from chemoradiotherapy in patients with local advanced NPC. Furthermore, the apparent side effects of Chinese medicine in this study have not been observed. Chinese medicine treatment did not affect the short-term clinical outcome.