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

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 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


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

Value
https://center6.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