UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Title of the study (Brief title)	Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Region	Japan

Condition
Condition	Patients with unresectable pancreatic cancer who are going to be treated with gemcitabine
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficay and safety of Rikkunshito on the development and progression in cancer cachexia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Change in body weight after 8 weeks from the start of treatment
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1,000 mg/m2 of Gemcitabine on day1, 8, 15, 29, 36, 43
Interventions/Control_2	1,000 mg/m2 of Gemcitabie on day1, 8, 15, 29, 36, 43, and 7.5 g/day of Rikkunshito for 8 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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.
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuhito Uezono, MD, PhD
Organization	National Cancer Center Research Insititute
Division name	Division of Cancer Pathophysiology
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN
TEL	03-3542-251
Email	yuezono@ncc.go.jp

Public contact
Name of contact person	Shunsuke Ohnishi, MD, PhD
Organization	Hokkaido University
Division name	Department of Gastroenterology, Graduate School of Medicine
Address	N15, W7, Kita-ku, Sapporo 060-8638 JAPAN
TEL	81+11-716-2111
Homepage URL
Email	sonishi@pop.med.hokudai.ac.jp

Sponsor
Institute	National Cancer Center Research Insititute
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 02 Month 29 Day
Anticipated trial start date	2012 Year 08 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 31 Day
Last modified on	2016 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009488