A randomized controlled, open-labelled early phase II trial comparing incidence of FOLFIRI.3-induced diarrhea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer

A randomized controlled, open-labelled early phase II trial comparing incidence of FOLFIRI.3-induced diarrhea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer - A randomized controlled, open-labelled early phase II trial comparing incidence of FOLFIRI.3-induced diarrhea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024219

Enrollment

Registered

2016-10-01

Start date

2008-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Hangeshashinto(TJ-14) Oral alkalization

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Eastern Cooperative Oncology Group performance status (PS)0-1 -Patients who have treated with FOLFORI-3 regimen -Patients with written informed consent

Exclusion criteria

Exclusion criteria: -patients who were contraindicated to the test drugs -patients with the record of serious (grade 3,4) drug allergy -patients with severe complication such as ileus uncontrolled diabetes hepatic or renal failure -pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
the incidence of all grade of a late-onset diarrhea during the treatment period	—

Secondary

Measure	Time frame
-the number of times taking antidiarrheal drug such as loperamide -medication compliance of the test drugs -response rate of FOLFIRI-3 therapy -duration of FOLFIRI-3 therapy -the incidence of all grade of adverse events other than diarrhea	—

Countries

Japan

Contacts

Public ContactKaori Yamazaki

Chiba University Hospital Division of Pharmacy

yamazakika@chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026