UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025606 |
|---|---|
| Receipt number | R000029467 |
| Scientific Title | A prospective interventional study of Japanese herbal medicine, Ninjin-Youei-To on fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2019/04/08 18:42:29 |
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Basic information
Public title
A prospective interventional study of Japanese herbal medicine, Ninjin-Youei-To on fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy
Acronym
A prospective interventional study of Ninjin-Youei-To on fatigue in patients who receive nab-paclitaxel plus gemcitabine therapy
Scientific Title
A prospective interventional study of Japanese herbal medicine, Ninjin-Youei-To on fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy
Scientific Title:Acronym
A prospective interventional study of Ninjin-Youei-To on fatigue in patients who receive nab-paclitaxel plus gemcitabine therapy
Region
| Japan |
Condition
Condition
Patients with unresectable pancreatic cancer
Classification by specialty
| Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy of Japanese herbal medicine, Ninjin-Yoiei-To, on fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy using several scores.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of fatigue and malaise using FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score untill eight weeks after stating chemotherapy.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
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)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
Key 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
073-441-0613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Okada |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
073-441-0613
Homepage URL
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Tsumura & Co., Tokyo, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 10 | 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
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unresectable pancreatic carcinoma
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029467
