UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014827
Receipt number R000015303
Scientific Title Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC)
Date of disclosure of the study information 2014/08/12
Last modified on 2018/02/12 09:17:39

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC)

Acronym

NYTBC

Scientific Title

Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC)

Scientific Title:Acronym

NYTBC

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify whether ninjinyoeito ameriolates hematotoxicity of FEC followed by docetaxel (including anthracyclin only, or other taxanes).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Frequency of neutropenia greater than grade 3 on day 10 of each cycle of chemotherapy

Key secondary outcomes

1. Use of G-CSF during the total period of chemotherapy
2. Relative dose intensity
3. Completion rate of the regimen
4. Hemoglobin concentration on day 10 of each chemotherapy cycle
5. Platelet count on day 10 of each chemotherapy cycle


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of Tsumura Ninjinyoeito extracted granules (for ethical use) 7.5 g/day (ref: http://kconsort.umin.jp). The intervention starts on day 1, and is continued until the end of the study for 24 weeks.

Interventions/Control_2

Non-administration of Tsumura Ninjinyoeito extracted granules (for ethical use)

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

80 years-old >=

Gender

Female

Key inclusion criteria

1. Pathologically-proven breast cancer
2. No prior chemotherapy
3. Adjuvant chemotherapy
4. PS is 1.

Key exclusion criteria

1. Blood transfusion within 7 days of registration
2. Pleural effusion and ascites
3. Multiple cancers
4. Severe drug hypersensitivity
5. Active infection
6. Severe ECG abnormalities
7. Severe pulmonary diseases
8. Ploblematic psychiatric disorders

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiharu Motoo

Organization

Kanazawa Medical University

Division name

Department of Medical Oncology

Zip code


Address

1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan

TEL

076-286-2211

Email

cancer@kanazawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiharu Motoo

Organization

Kanazawa Medical University

Division name

Department of Medical Oncology

Zip code


Address

1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan

TEL

076-286-2211

Homepage URL


Email

cancer@kanazawa-med.ac.jp


Sponsor or person

Institute

Department of Medical Oncology, Kanazawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Oncology, Kanazawa Medical University

Organization

Division

Category of Funding Organization

Self funding

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

金沢医科大学病院(石川県)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 12 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

The significance of this trial was lost due to the use of PEG-G-CSF.

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

Completed

Date of protocol fixation

2014 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 20 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry

2017 Year 10 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2018 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 11 Day

Last modified on

2018 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015303


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name