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

Kaori Yamazaki, Noritaka Ariyoshi, Hideaki Miyauchi, Gaku Ohira, Noriko Kaneya, Kohei Yamamoto, Kenichi Arai, Shingo Yamazaki, Hisahiro Matsubara, Takaaki Suzuki, Itsuko Ishii

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Abstract

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.

Original languageEnglish
JournalJournal of Clinical Pharmacy and Therapeutics
DOIs
Publication statusAccepted/In press - Jan 1 2019
Externally publishedYes

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Keywords

  • alkalization
  • diarrhoea
  • FOLFIRI.3
  • Hangeshashinto
  • RCT

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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