Patients with unresectable pancreatic cancer who are going to be treated with gemcitabine
Conditions
Interventions
1,000 mg/m2 of Gemcitabine on day1, 8, 15, 29, 36, 43
1,000 mg/m2 of Gemcitabie on day1, 8, 15, 29, 36, 43, and 7.5 g/day of Rikkunshito for 8 weeks.
Sponsors
National Cancer Center Research Insititute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically diagnosed pancreatic cancer 2) Patients who signed a written informed consent 3) The pancreatic cancer notification was given 4) Unresectable pancreatic cancer 5) Unintentional body weight loss of <=in 6 months 6) Age 20 or older 7) Eastern Cooperative Oncology Group (ECOG) Performance Status Grade of 0-2 8) Patients have a measurable lesion of the pancratic cancer 9) No history of chemotherapy or radiation therapy 10) Patients are scheduled to be treated with gemcitabine alone 11) No other Kampo medicines are administrated 12) Expected to survive >= 3months 13) Sufficient oral intake 14) Laboratory test results within these ranges: 1. White blood cell count>=2000/microliter and <=8000/microliter 2. Platelet count >=70000/microliter 3. Total bilirubin <=2.0mg/dL 4. AST <=100 IU/L 5. ALT <=100 IU/L 6. K >=3.0 mEq/L 7. Creatinine clearance >=60 mL/min
Exclusion criteria
Exclusion criteria: 1)Patients with cerebral metastases 2)Patients with peritoneal or pleural dissemination 3)Patients with ascites or pleural effusion 4)Patients with double cancer 5)Patients with interstitial pneumonia, lung fibrosis and severe pulmonary emphysema 6)Patinets with seizure disorder requiring anticonvulsants 7)Patients with disturbed consciousness 8)Patinets with gastrointestinal obstruction 9)Patients participating in other clinical trials 10)Patients with uncontrollable hypertension 11)Patients with diabetes mellitus treated with insulin, or uncontrollable diabetes mellitus 12)Patients with taking corticosteroid, androgen, progesterone or any other orexigenic medicine 13)Pregnant woman, Nursing woman, or woman not to agree with contraception 14)Pateints with infection requiring systemic treatment 15)Patiens having body temperature of >=38degrees at the enrollment 16)Patients with psychiatric disorder or any psychiatric symptoms, or considered in ineligible to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight after 8 weeks from the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lean body mass, fat mass, FAACT ACS score, handgrip, rapid turnover proteins, plasma ghrelin level in fasting state and tumor reduction rate, after 8weeks from the start of treatment. Progression free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactShunsuke Ohnishi, MD, PhD
Hokkaido University Department of Gastroenterology, Graduate School of Medicine
Outcome results
None listed