Randomized Phase Ii Study Of Hangeshashinto (Tj-14) For Chemotherapy Induced Oral Mucositis In Patients With Breast Cancer (Hangesha-B Study)

Background: Oral mucositis is a common complication of systemic chemotherapy for cancer, and is associated with higher risk of infection, pain, chemotherapy dose reduction. Severe mucositis impairs oral function and seriously affects nutrition and quality of life of the patients. Hangeshashinto (TJ-14) is a traditional Japanese herbal (Kampo) medicine reduces the level of prostaglandin E2 and affects the cyclooxygenase activity, and alleviates chemotherapy induced oral mucositis. We conducted a randomized phase II trial to investigate whether Hangeshashinto (TJ-14) prevents or controls chemotherapy induced oral mucositis. Patients and Methods: Patients who develop moderate to severe chemotherapy induced oral mucositis (WHO gradeu003e1) during any cycle of chemotherapy are randomly assigned to receive either Hangeshashinto (TJ-14) (n=25) or placebo (n=25). Patients receive the administration of Hangeshashinto (TJ-14) or placebo for 3 weeks at the beginning of the next course of chemotherapy. The patients are advised to dissolve 2.5g of Hangeshashinto (TJ-14) or placebo in 50ml drinking water, and divide it into twice or three times in an oral cavity. Patients rinse their oral cavity with it three times daily. The signs of oral mucositis is assessed by the investigator during the screening cycle. The CTCAE v4.0 grading is used to assess the severity of oral mucositis. The primary endpoint is duration time of oral mucositis, and secondary endpoints include incidence of oral mucositis, incidence of diarrhea, blood levels of CRP, The change of body weight, and blood levels of albumin. Accrual: This study began in June 2015. The expected end of accrual of 50 patients will be the last quarter 2017. Citation Format: Iwamoto M, Umezaki N, Matsuda J, Kawaguchi K, Terasawa R, Sato N, Fyjioka H, Kimura K, Tanaka S, Uchiyama K. Randomized phase II study of Hangeshashinto (TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer (Hangesha-B study). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-02-01.