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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008066
Receipt No. 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

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Basic information
Public title Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Acronym Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Scientific Title Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhito Uezono, MD, PhD
Organization National Cancer Center Research Insititute
Division name Division of Cancer Pathophysiology
Zip code
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
1st name
Middle name
Last name Shunsuke Ohnishi, MD, PhD
Organization Hokkaido University
Division name Department of Gastroenterology, Graduate School of Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 02 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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