Cargando…

Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis

BACKGROUND: 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 randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patie...

Descripción completa

Detalles Bibliográficos
Autores principales: Aoyama, Toru, Nishikawa, Kazuhiro, Takiguchi, Nobuhiro, Tanabe, Kazuaki, Imano, Motohiro, Fukushima, Ryoji, Sakamoto, Junichi, Oba, Mari S., Morita, Satoshi, Kono, Toru, Tsuburaya, Akira
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4000413/
https://www.ncbi.nlm.nih.gov/pubmed/24652604
http://dx.doi.org/10.1007/s00280-014-2440-x
_version_ 1782313616185229312
author Aoyama, Toru
Nishikawa, Kazuhiro
Takiguchi, Nobuhiro
Tanabe, Kazuaki
Imano, Motohiro
Fukushima, Ryoji
Sakamoto, Junichi
Oba, Mari S.
Morita, Satoshi
Kono, Toru
Tsuburaya, Akira
author_facet Aoyama, Toru
Nishikawa, Kazuhiro
Takiguchi, Nobuhiro
Tanabe, Kazuaki
Imano, Motohiro
Fukushima, Ryoji
Sakamoto, Junichi
Oba, Mari S.
Morita, Satoshi
Kono, Toru
Tsuburaya, Akira
author_sort Aoyama, Toru
collection PubMed
description BACKGROUND: 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 randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer. METHODS: We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis (CTCAE v4.0 grade ≧1) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial. The patients received a placebo or TJ-14 for 2–6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy. The primary end point was the incidence of grade ≧2 oral mucositis in the protocol treatment course, and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events. RESULTS: Following the key opening of the blinding protocol, we analyzed 91 eligible patients (TJ-14: 45, placebo: 46) using a “per protocol set” analysis. The incidence of ≧grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group (p = 0.588). The median duration of ≧grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group (p = 0.894). Meanwhile, the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [hazard ratio 0.60; 95 % CI (0.23–1.59), p = 0.290]. CONCLUSIONS: Although TJ-14 treatment did not reduce the incidence of ≥2 COM in the patients who developed mucositis during chemotherapy for gastric cancer, a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle. Further, phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM.
format Online
Article
Text
id pubmed-4000413
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher Springer Berlin Heidelberg
record_format MEDLINE/PubMed
spelling pubmed-40004132014-05-07 Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis Aoyama, Toru Nishikawa, Kazuhiro Takiguchi, Nobuhiro Tanabe, Kazuaki Imano, Motohiro Fukushima, Ryoji Sakamoto, Junichi Oba, Mari S. Morita, Satoshi Kono, Toru Tsuburaya, Akira Cancer Chemother Pharmacol Original Article BACKGROUND: 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 randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer. METHODS: We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis (CTCAE v4.0 grade ≧1) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial. The patients received a placebo or TJ-14 for 2–6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy. The primary end point was the incidence of grade ≧2 oral mucositis in the protocol treatment course, and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events. RESULTS: Following the key opening of the blinding protocol, we analyzed 91 eligible patients (TJ-14: 45, placebo: 46) using a “per protocol set” analysis. The incidence of ≧grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group (p = 0.588). The median duration of ≧grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group (p = 0.894). Meanwhile, the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [hazard ratio 0.60; 95 % CI (0.23–1.59), p = 0.290]. CONCLUSIONS: Although TJ-14 treatment did not reduce the incidence of ≥2 COM in the patients who developed mucositis during chemotherapy for gastric cancer, a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle. Further, phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM. Springer Berlin Heidelberg 2014-03-21 2014 /pmc/articles/PMC4000413/ /pubmed/24652604 http://dx.doi.org/10.1007/s00280-014-2440-x Text en © The Author(s) 2014 https://creativecommons.org/licenses/by/4.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Article
Aoyama, Toru
Nishikawa, Kazuhiro
Takiguchi, Nobuhiro
Tanabe, Kazuaki
Imano, Motohiro
Fukushima, Ryoji
Sakamoto, Junichi
Oba, Mari S.
Morita, Satoshi
Kono, Toru
Tsuburaya, Akira
Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis
title Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis
title_full Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis
title_fullStr Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis
title_full_unstemmed Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis
title_short Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis
title_sort double-blind, placebo-controlled, randomized phase ii study of tj-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4000413/
https://www.ncbi.nlm.nih.gov/pubmed/24652604
http://dx.doi.org/10.1007/s00280-014-2440-x
work_keys_str_mv AT aoyamatoru doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT nishikawakazuhiro doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT takiguchinobuhiro doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT tanabekazuaki doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT imanomotohiro doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT fukushimaryoji doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT sakamotojunichi doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT obamaris doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT moritasatoshi doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT konotoru doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis
AT tsuburayaakira doubleblindplacebocontrolledrandomizedphaseiistudyoftj14hangeshashintoforgastriccancerchemotherapyinducedoralmucositis