The feasibility study of Oral rehydration therapy for Short hydration in chemotherapy with cisplatin plus gemcitabine for biliary tract cancer

The feasibility study of Oral rehydration therapy for Short hydration in chemotherapy with cisplatin plus gemcitabine for biliary tract cancer - Oral rehydration therapy for Short hydration in chemotherapy with CDDP plus GEM for biliary tract cancer: KHBO1302

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010695

Enrollment

Registered

2013-05-13

Start date

2013-06-24

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

biliary tract cancer

Interventions

Short hydration via oral rehydration solution (OS-1) Standard hydration via intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histological or cytological diagnosis of biliary tract cancer who haven't received cisplatin previously 2. Patients who is planned to receive chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks 3. Older than 20 years old 4. PS 0 or 1 5. Adequate main organ function 6. Fully oral intake ability to drink 500ml of solution before chemotherapy 7. Estimated life expectancy no less than 3 months 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who received cisplatin previously 2. Radiological and clinical evidence of pulmonary fibrosis or interstitial pneumonia 3. Patients with uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial infarction within 3 months 4. Patients with serious infection 5. Pregnant or lactating female or patients who wish pregnant 6. Patients having severe allergy 7. Patients with other serious comorbid diseases 8. Patients with severe psychological disease 9. Patients with uncontrollable watery diarrhea 10. Patients with moderate or severe ascites /pleural effusion 11. Patients with severe psychological disease 12. Patients who are positive for a test of hepatitis B virus surface antigen (HBs antigen) without controlled with entecavir 13. Patients who is judged as an inappropriate case by the investigator

Design outcomes

Primary

Measure	Time frame
Completion rate during the 12 weeks in the short hydration group	—

Secondary

Measure	Time frame
Rate of renal toxicity, adverse events, marker of renal function, response rate, time to treatment failure, progression free survival, overall survival	—

Countries

Japan

Contacts

Public ContactDaisuke Sakai

Osaka University, Graduate School of Medicine Department of Frontier Science for Cancer and Chemotherapy

dsakai@cfs.med.osaka-u.ac.jp0668792641

Outcome results

None listed

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