An exploratory study on the efficacy and safety of Hangesyasinto (TJ-14) for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in the patients with advanced esophageal cancer.

An exploratory study on the efficacy and safety of Hangesyasinto (TJ-14) for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in the patients with advanced esophageal cancer. - Effect of Hangesyasinto for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in patients with advanced esophageal cancer.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023825

Enrollment

Registered

2016-08-29

Start date

2016-08-30

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

esophageal cancer

Interventions

TJ-14 TSUMURA Hangeshashinto Extract Granules for Ethical Use. Oral administration of Hangeshashinto (7.5g/day t.i.d. before meals) for 4 weeks after the start of 2nd course of DCF chemotherapy or DCF

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. confirmed esophageal cancer by histological diagnosis 2. developed diarrhea more than CTCAE Grade1 on the 1st course of DCF chemotherapy or DCR-RT chemoradiotherapy 3. stage 2-4 of esophageal cancer progression 4. survival is expected for three months at least after administration 5. Performance Status 0-2 6. No dysfunction of major organs (heart, lung, liver, kidney, and bone marrow) 7. hospitalization 8. have given written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. aldosteronism 2. myopathy or hypokalemia 3. while taking the Kampo medicines 4. less than 4 weeks after previous chemo or radio completion 5. medical history of serious drug allergy 6. presence of serious complications (heart, lung, liver, or kidney disease or psychological disorders or bleeding) 7. HBV, HCV infection 8. pregnant or breast-feeding females and females who have a possibility of pregnancy 9. patients who are thought inadequate by their doctor

Design outcomes

Primary

Measure	Time frame
Stool frequency for 4 weeks after the start of administration	—

Secondary

Measure	Time frame
1. Period and incidence rate of diarrhea more than CTCAE Grade2 for 4 weeks after administration 2. Stool consistency (Bristol stool scale) for 4 weeks after administration 3. Diamine oxidase activity [Before administration, at week 1 and 4] 4. The number of completion patients of DCF chemotherapy or DCF-RT chemoradiotherapy 5.Adverse event/reactions	—

Countries

Japan

Contacts

Public ContactMasanobu nakajima

Dokkyo Medical University Department of Surgery 1

mnakajim@dokkyomed.ac.jp0282-86-1111

Outcome results

None listed

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