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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025606
Receipt No. 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

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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
Email 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
Email okada@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029467

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/03/27 mco.2017.Fatigue_PDF.pdf


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