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Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial

The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The seco...

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Autores principales: Murai, Taro, Matsuo, Masayuki, Tanaka, Hidekazu, Manabe, Yoshihiko, Takaoka, Taiki, Hachiya, Kae, Yamaguchi, Takahiro, Otsuka, Shinya, Shibamoto, Yuta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7022136/
https://www.ncbi.nlm.nih.gov/pubmed/31691810
http://dx.doi.org/10.1093/jrr/rrz025
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author Murai, Taro
Matsuo, Masayuki
Tanaka, Hidekazu
Manabe, Yoshihiko
Takaoka, Taiki
Hachiya, Kae
Yamaguchi, Takahiro
Otsuka, Shinya
Shibamoto, Yuta
author_facet Murai, Taro
Matsuo, Masayuki
Tanaka, Hidekazu
Manabe, Yoshihiko
Takaoka, Taiki
Hachiya, Kae
Yamaguchi, Takahiro
Otsuka, Shinya
Shibamoto, Yuta
author_sort Murai, Taro
collection PubMed
description The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean ± SD: 4.9 ± 2.1 vs 3.7 ± 1.9, P = 0.02). This effect continued at 2 (2.2 ± 1.4, P = 0.004) and 3 weeks (2.1 ± 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned.
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spelling pubmed-70221362020-02-20 Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial Murai, Taro Matsuo, Masayuki Tanaka, Hidekazu Manabe, Yoshihiko Takaoka, Taiki Hachiya, Kae Yamaguchi, Takahiro Otsuka, Shinya Shibamoto, Yuta J Radiat Res Regular Paper The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean ± SD: 4.9 ± 2.1 vs 3.7 ± 1.9, P = 0.02). This effect continued at 2 (2.2 ± 1.4, P = 0.004) and 3 weeks (2.1 ± 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned. Oxford University Press 2019-11-06 /pmc/articles/PMC7022136/ /pubmed/31691810 http://dx.doi.org/10.1093/jrr/rrz025 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of The Japanese Radiation Research Society and Japanese Society for Radiation Oncology. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Regular Paper
Murai, Taro
Matsuo, Masayuki
Tanaka, Hidekazu
Manabe, Yoshihiko
Takaoka, Taiki
Hachiya, Kae
Yamaguchi, Takahiro
Otsuka, Shinya
Shibamoto, Yuta
Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
title Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
title_full Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
title_fullStr Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
title_full_unstemmed Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
title_short Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
title_sort efficacy of herbal medicine tj-14 for acute radiation-induced enteritis: a multi-institutional prospective phase ii trial
topic Regular Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7022136/
https://www.ncbi.nlm.nih.gov/pubmed/31691810
http://dx.doi.org/10.1093/jrr/rrz025
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