title: Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis.
abstract: OBJECTIVE
  Hangeshashinto (TJ-14, a Kampo medicine), which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity, alleviates chemotherapy-induced oral mucositis (COM). We conducted a double-blind, placebo-controlled, randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with colorectal cancer.
  
  
  METHODS
  Ninety-three patients with colorectal cancer who developed moderate-to-severe COM (WHO grade ≧1) during any cycle of chemotherapy using FOLFOX, FOLFIRI, and/or XELOX treatment were randomly assigned to receive either TJ-14 (n = 46) or placebo (n = 47). Patients received the administration of placebo or TJ-14 for 2 weeks at the start of the next course of chemotherapy. Patients were assessed three times per week for safety and for COM incidence and its severity using the WHO grading.
  
  
  RESULTS
  Ninety eligible patients (TJ-14; 43, placebo; 47) per protocol set analysis were included in the analysis after the key-opening. Although the incidence of grade ≧2 oral mucositis was lower for patients treated with TJ-14 compared to those treated with placebo, there was no significant difference (48.8 vs. 57.4 %; p = 0.41). The median duration of grade ≧2 mucositis was 5.5 versus 10.5 days (p = 0.018). No difference in other treatment toxicity was observed between the two groups, and patients exhibited high compliance in dosing administration.
  
  
  CONCLUSIONS
  The present study results did not meet the primary endpoint. However, TJ-14 demonstrated a significant effect in the treatment of grade ≧2 mucositis in patients with colorectal cancer compared to the placebo.
authors.affiliation: Department of Surgery, Osaka General Medical Center, Osaka, Japan.
authors.forename: Chu
authors.initials: C
authors.lastname: Matsuda
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Munemoto
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Mishima
authors.forename: Naoki
authors.initials: N
authors.lastname: Nagata
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Oshiro
authors.forename: Masato
authors.initials: M
authors.lastname: Kataoka
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Toru
authors.initials: T
authors.lastname: Aoyama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Toru
authors.initials: T
authors.lastname: Kono
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010071:Oxaloacetates; D011788:Quality of Life; D013280:Stomatitis / Q000139:chemically induced* / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; D009944:Organoplatinum Compounds; D010071:Oxaloacetates; C088236:hange-shashinto; D003841:Deoxycytidine; D000069287:Capecitabine; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin