Patients with unresectable pancreatic cancer
Conditions
Interventions
TJ-108(Ninjin-Youei-To) at a dose of 3g (15g/day) was administered orally as a solution three times daily immediately befire meals or every 8h for 8 weeks.
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patient with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine 2)Patient with pancreatic cancer stage UICC TNM classification III-IV 3)Estimated overall survival>3months 4)ECOG-PS 0 or 1 5)Main organs function test almost within normal range: WBC>=3,500/mm3, <=12,000/mm3 Neutrophil>=1,500/mm3 Platelet>=100,000/mm3 Hemoglobin>=9.0g/dl AST, ALT<=100IU/l Total bilirubin<=2.0mg/dl,In biliary drainage cases<3.0mg/dl Creatinine<=1.2mg/dl 6)Age>=20 years old 7)Outpatient clinic patient 8)Informed concent was obtained
Exclusion criteria
Exclusion criteria: 1)Patients with severe co-morbidity such as heart failure, renal failure, or bowel obstruction. 2)Patients with pregnancy. 3)Patients with active cancer of other organs. 4)Patients with intorerable of oral medications. 5)Patients who is not suitable for undergoing the study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of fatigue and malaise using FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score untill eight weeks after stating chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of appetite loss using NRS(Numerical Rating Scale), peripheral neuropathy using PNQ(Patient Neurotoxicity Questionnaire), sensitive disorders using NRS, nutritional data, anemia using CTCAE criteria, accomplishment of chemotherapy schedule, usage rate of G-CSF, steroids etc., relative dose intensity. | — |
Countries
Japan
Contacts
Public ContactKen-ichi Okada
Wakayama Medical University Second Department of Surgery
Outcome results
None listed