Unique ID issued by UMIN | UMIN000008066 |
---|---|
Receipt number | R000009488 |
Scientific Title | Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study |
Date of disclosure of the study information | 2012/05/31 |
Last modified on | 2016/12/02 14:35:15 |
Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Japan |
Patients with unresectable pancreatic cancer who are going to be treated with gemcitabine
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficay and safety of Rikkunshito on the development and progression in cancer cachexia
Safety,Efficacy
Exploratory
Phase II
Change in body weight after 8 weeks from the start of treatment
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
40
1st name | |
Middle name | |
Last name | Yasuhito Uezono, MD, PhD |
National Cancer Center Research Insititute
Division of Cancer Pathophysiology
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN
03-3542-251
yuezono@ncc.go.jp
1st name | |
Middle name | |
Last name | Shunsuke Ohnishi, MD, PhD |
Hokkaido University
Department of Gastroenterology, Graduate School of Medicine
N15, W7, Kita-ku, Sapporo 060-8638 JAPAN
81+11-716-2111
sonishi@pop.med.hokudai.ac.jp
National Cancer Center Research Insititute
Ministry of Health, Labour and Welfare
Japanese Governmental office
JAPAN
NO
北海道大学病院(北海道)
釧路労災病院(北海道)
苫小牧市立病院(北海道)
市立札幌病院(北海道)
市立函館病院(北海道)
北見赤十字病院(北海道)
北海道消化器科病院(北海道)
札幌北楡病院(北海道)
苫小牧日翔病院(北海道)
網走厚生病院(北海道)
函館中央病院(北海道)
札幌社会保険総合病院(北海道)
市立稚内病院(北海道)
愛育病院(北海道)
大阪医科大学 (大阪)
金沢医科大学 (石川)
2012 | Year | 05 | Month | 31 | Day |
Unpublished
Terminated
2012 | Year | 02 | Month | 29 | Day |
2012 | Year | 08 | Month | 16 | Day |
2012 | Year | 05 | Month | 31 | Day |
2016 | Year | 12 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009488