UMIN-CTR Clinical Trial
| 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 |
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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
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
sonishi@pop.med.hokudai.ac.jp
Sponsor or person
Institute
National Cancer Center Research Insititute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009488
