{Reference Type}: Clinical Trial, Phase II
{Title}: Efficacy of Kanglaite against radiotherapy-induced mucositis in head and neck cancer, a phase II trial.
{Author}: Liu ZP;Song QY;Chu CL;Liu SH;Ren YX;Chen J;Zhang DX;
{Journal}: Cancer Radiother
{Volume}: 26
{Issue}: 4
{Year}: Jun 2022
{Factor}: 1.217
{DOI}: 10.1016/j.canrad.2021.11.024
{Abstract}: <B>OBJECTIVE: </B>To explore the potential protective effect of Kanglaite injection against radiotherapy-induced mucositis in patients with head and neck cancer.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.