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Effect of omega-3 fatty acids administration in adjuvant chemotherapy for biliary tract cancer: an open-label, single-arm study.

Effect of omega-3 fatty acids administration in adjuvant chemotherapy for biliary tract cancer: an open-label, single-arm study. - Study of the effect of omega-3 fatty acids in biliary tract cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031247
Enrollment
55
Registered
2018-03-20
Start date
2018-08-01
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

Biliary tract chancer

Interventions

Omega-3 fatty acids administration during adjuvant chemotherapy

Sponsors

Kobe University Graduate School of Medicine Department of Surgery Division of Hepato-Biliary-Pancreatic Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) patients after resection of biliary tract cancer (2) patients pathologically diagnosed as adenocarcinoma or adenosquamous cell carcinoma and Stage2,3, and 4 (3) patients whose Performance Status is 0 or 1 (4) patients who is possible oral intake (5) patients who meet the following criteria; 1. Neut is higher or equal to 1,200/mm3 2. Plt is higher or equal to 10,000/mm3 3. Hb is higher or equal to 8.0g/dL 4. T-Bil is lower or equal to 2.0mg/dL 5. AST(GOT) is lower or equal to 100IU/L 6. ALT(GPR) is lower or equal to 100IU/L 7. Serum Cre is lower or equal to 1.2mg/dL 8. Ccr is higher or equal to 40ml/min 9. Tcho is higher or equal to 100mg/dL and TG is higher or equal to 20mg/dL 10. PT% is higher or equal to 50%, PT-INR is lower or equal to 2.0, and APTT is lower or equal to 50sec (except the patients taking warfarin) (6) patients who gained document by their own voluntary intention

Exclusion criteria

Exclusion criteria: (1) patients with severe liver or renal dysfunction (2) patients with drug hypersensitivity (3) patients judged as inappropriate by researcher

Design outcomes

Primary

MeasureTime frame
completion rate in adjuvant chemotherapy with TS-1

Secondary

MeasureTime frame
Detail of cholangitis Adverse effect Recurrence and prognosis Nutrition status Immune status

Countries

Japan

Contacts

Public ContactKimihiko Ueno

Kobe University Graduate School of Medicine Department of Surgery Division of Hepato-Biliary-Pancreatic Surgery

kueno.rhmn@gmail.com078-382-6302

Outcome results

None listed

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