Abstract：
OBJECTIVE: To explore the potential protective effect of Kanglaite injection against radiotherapy-induced mucositis in patients with head and neck cancer.
METHODS: This was an open-label, single-arm, and phase II trial. The primary endpoint was the incidence of grade 3-4 radiation-induced mucositis. The secondary endpoints were hematological toxicity, non-hematological toxicity, nutritional status, and quality of life. All patients received 20g Kanglaite daily concurrently with radiotherapy.
RESULTS: The data of 46 patients were available for analysis. The incidence rates of grade 3 mucositis, pain, dysphagia, and neutropenia were 10.9%, 2.2%, 10.9%, and 6.5%, respectively, while the incidence of grade 4 acute toxicities was zero. The rate of opioid use was 2.2%. Radiotherapy dose reduction was 2.2% and no irradiation field was modified. The nutritional supports were oro-enteral nutritional supplements (13.0%), TPN (10.9%), and feeding tubes (0%) during radiotherapy. After radiotherapy, 52.2% of patients lost weight, and the weight loss was <10%. The mean pain score in the QLQ-H&N35 and QLQ-C30 was <50. Patients had nearly normal physical, emotional, and cognitive functions.
CONCLUSIONS: A low incidence of grade 3-4 radiation-induced mucositis and no severe acute toxic events, with favorable nutritional status and quality of life, were observed in cancer patients after Kanglaite injection. Our findings highlight the need for a prospective, multicenter, and randomized study to investigate the effect of Kanglaite injection on the reduction of radiation-induced mucositis in patients with head and neck cancer.
METHODS: This was an open-label, single-arm, and phase II trial. The primary endpoint was the incidence of grade 3-4 radiation-induced mucositis. The secondary endpoints were hematological toxicity, non-hematological toxicity, nutritional status, and quality of life. All patients received 20g Kanglaite daily concurrently with radiotherapy.
RESULTS: The data of 46 patients were available for analysis. The incidence rates of grade 3 mucositis, pain, dysphagia, and neutropenia were 10.9%, 2.2%, 10.9%, and 6.5%, respectively, while the incidence of grade 4 acute toxicities was zero. The rate of opioid use was 2.2%. Radiotherapy dose reduction was 2.2% and no irradiation field was modified. The nutritional supports were oro-enteral nutritional supplements (13.0%), TPN (10.9%), and feeding tubes (0%) during radiotherapy. After radiotherapy, 52.2% of patients lost weight, and the weight loss was <10%. The mean pain score in the QLQ-H&N35 and QLQ-C30 was <50. Patients had nearly normal physical, emotional, and cognitive functions.
CONCLUSIONS: A low incidence of grade 3-4 radiation-induced mucositis and no severe acute toxic events, with favorable nutritional status and quality of life, were observed in cancer patients after Kanglaite injection. Our findings highlight the need for a prospective, multicenter, and randomized study to investigate the effect of Kanglaite injection on the reduction of radiation-induced mucositis in patients with head and neck cancer.
摘要：
目的：探讨康莱特注射液对头颈部肿瘤患者放疗所致黏膜炎的潜在保护作用。
方法：这是一个开放标签，单臂,和第二阶段试验。主要终点是3-4级放射性粘膜炎的发生率。次要终点是血液学毒性，非血液学毒性，营养状况,和生活质量。所有患者每天接受20g康莱特，同时接受放疗。
结果：46例患者的数据可用于分析。3级黏膜炎的发病率，疼痛,吞咽困难,中性粒细胞减少为10.9%,2.2%,10.9%,和6.5%，分别,而4级急性毒性的发生率为零。阿片类药物使用率为2.2%。放射治疗剂量减少了2.2％，没有改变照射场。营养支持为口肠内营养补充剂(13.0%)，TPN（10.9%），放疗期间和饲管(0%)。放疗后,52.2%的患者体重下降,并且重量损失<10%。QLQ-H&N35和QLQ-C30的平均疼痛评分<50。患者的身体几乎正常，情感,和认知功能。
结论：3-4级放射性黏膜炎发生率低，无严重急性中毒性事件，良好的营养状况和生活质量，在康莱特注射后的癌症患者中观察到。我们的发现强调了对未来的需求，多中心，和随机研究，以探讨康莱特注射液对头颈部肿瘤患者放射性黏膜炎的减轻作用。
方法：这是一个开放标签，单臂,和第二阶段试验。主要终点是3-4级放射性粘膜炎的发生率。次要终点是血液学毒性，非血液学毒性，营养状况,和生活质量。所有患者每天接受20g康莱特，同时接受放疗。
结果：46例患者的数据可用于分析。3级黏膜炎的发病率，疼痛,吞咽困难,中性粒细胞减少为10.9%,2.2%,10.9%,和6.5%，分别,而4级急性毒性的发生率为零。阿片类药物使用率为2.2%。放射治疗剂量减少了2.2％，没有改变照射场。营养支持为口肠内营养补充剂(13.0%)，TPN（10.9%），放疗期间和饲管(0%)。放疗后,52.2%的患者体重下降,并且重量损失<10%。QLQ-H&N35和QLQ-C30的平均疼痛评分<50。患者的身体几乎正常，情感,和认知功能。
结论：3-4级放射性黏膜炎发生率低，无严重急性中毒性事件，良好的营养状况和生活质量，在康莱特注射后的癌症患者中观察到。我们的发现强调了对未来的需求，多中心，和随机研究，以探讨康莱特注射液对头颈部肿瘤患者放射性黏膜炎的减轻作用。
