Efficacy of Kanglaite against radiotherapy-induced mucositis in head and neck cancer, a phase II trial

作者：Liu, Z. -P.; Song, Q. -Y.; Chu, C. -l.; Liu, S. -H.; Ren, Y. -X.; Chen, J.; Zhang, D. -X.^*

来源：Cancer Radiotherapie, 2022, 26(4): 585-593.

DOI：10.1016/j.canrad.2021.11.024

• Mucositis
• Radiotherapy
• Head and neck neoplasms
• Kanglaite

Purpose. - To explore the potential protective effect of Kanglaite injection against radiotherapy-induced mucositis in patients with head and neck cancer. Patients and 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 20 g 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.

• 单位
  哈尔滨医科大学; 1