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Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis.

AbstractPURPOSE:
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.
CONCLUSION:
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.
AuthorsChu Matsuda, Yoshinori Munemoto, Hideyuki Mishima, Naoki Nagata, Mitsuru Oshiro, Masato Kataoka, Junichi Sakamoto, Toru Aoyama, Satoshi Morita, Toru Kono
JournalCancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 76 Issue 1 Pg. 97-103 (Jul 2015) ISSN: 1432-0843 [Electronic] Germany
PMID25983022 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Drugs, Chinese Herbal
  • Organoplatinum Compounds
  • Oxaloacetates
  • hange-shashinto
  • Deoxycytidine
  • Capecitabine
  • Leucovorin
  • Fluorouracil
  • Camptothecin
Topics
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
  • Capecitabine
  • Colorectal Neoplasms (drug therapy)
  • Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
  • Double-Blind Method
  • Drugs, Chinese Herbal (therapeutic use)
  • Female
  • Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
  • Humans
  • Leucovorin (administration & dosage, adverse effects)
  • Male
  • Middle Aged
  • Organoplatinum Compounds (administration & dosage, adverse effects)
  • Oxaloacetates
  • Quality of Life
  • Stomatitis (chemically induced, prevention & control)
  • Young Adult

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