KMCRIC

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

Matsuda C, Munemoto Y, Mishima H, Nagata N, Oshiro M, Kataoka M, Sakamoto J, Aoyama T, Morita S, Kono T.

Cancer Chemother Pharmacol.

2015

76(1)

97-103.

10.1007/s00280-015-2767-y.

25983022

http://www.ncbi.nlm.nih.gov/pubmed/25983022

Adult
Aged
Antineoplastic Combined Chemotherapy Protocols/administration & dosage
Antineoplastic Combined Chemotherapy Protocols/adverse effects*
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Camptothecin/administration & dosage
Camptothecin/adverse effects
Camptothecin/analogs & derivatives
Colorectal Neoplasms/drug therapy*
Deoxycytidine/administration & dosage
Deoxycytidine/adverse effects
Deoxycytidine/analogs & derivatives
Double-Blind Method
Drugs, Chinese Herbal/therapeutic use*
Female
Fluorouracil/administration & dosage
Fluorouracil/adverse effects
Fluorouracil/analogs & derivatives
Humans
Leucovorin/administration & dosage
Leucovorin/adverse effects
Male
Middle Aged
Organoplatinum Compounds/administration & dosage
Organoplatinum Compounds/adverse effects
Quality of Life
Stomatitis/chemically induced*
Stomatitis/prevention & control*
Young Adult

Hangeshashinto; TJ-14; Colorectal Cancer; Oral mucositis

반하사심탕; 반하사심탕; 대장암; 구강점막염

KMCRIC 비평 보기 +

PURPOSE:
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.

영어