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A randomized controlled, open‐label early phase II trial comparing incidence of FOLFIRI.3‐induced diarrhoea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer
Author(s) -
Yamazaki Kaori,
Ariyoshi Noritaka,
Miyauchi Hideaki,
Ohira Gaku,
Kaneya Noriko,
Yamamoto Kohei,
Arai Kenichi,
Yamazaki Shingo,
Matsubara Hisahiro,
Suzuki Takaaki,
Ishii Itsuko
Publication year - 2019
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.13020
Subject(s) - medicine , folfiri , gastroenterology , clinical endpoint , colorectal cancer , randomized controlled trial , regimen , incidence (geometry) , adverse effect , phases of clinical research , clinical trial , surgery , cancer , irinotecan , physics , optics
What is known and objective We conducted a pilot clinical trial to investigate whether Hangeshashinto (TJ‐14) could be substituted for oral alkalization in patients scheduled to undergo chemotherapy by FOLFIRI.3 regimen for colorectal cancer (CRC). Methods Patients with CRC were randomized 1:1 to a TJ‐14 (7.5 g/day) group or an oral alkalization (sodium bicarbonate, 1.8 g/day; ursodeoxycholic acid, 300 mg/day) group. The primary endpoint was incident of late‐onset diarrhoea. A total of 30 patients were randomized to either the TJ‐14 group or the alkalization group. Results and discussion There was no statistical difference in age, concomitantly used drugs or UGT1A1 genotypes between the groups. In the alkalization group (n = 15), the frequency of grade 0/1/2 and grade 3 diarrhoea was 73% and 27%, respectively. In the TJ‐14 group (n = 14), the frequency of grade 0/1/2 and grade 3 diarrhoea was 79% and 21%, respectively. Grade 4 diarrhoea was not observed in either group. There was no statistically significant difference in other adverse events or in response to FOLFIRI.3 between the groups. What is new and conclusion This pilot trial suggests that TJ‐14 is a promising alternative treatment option to reduce FOLFIRI.3‐induced late‐onset diarrhoea, although additional clinical study with a larger number of patients is necessary to confirm these results.