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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008646
Receipt No. R000010158
Scientific Title Efficacy of Dietary Supplements Inner-power for Chemotherapy Induced Fatigue in Breast Cancer
Date of disclosure of the study information 2012/08/08
Last modified on 2016/07/25

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Basic information
Public title Efficacy of Dietary Supplements Inner-power for Chemotherapy Induced Fatigue in Breast Cancer
Acronym Efficacy of Dietary Supplements Inner-power for Chemotherapy Induced Fatigue in Breast Cancer
Scientific Title Efficacy of Dietary Supplements Inner-power for Chemotherapy Induced Fatigue in Breast Cancer
Scientific Title:Acronym Efficacy of Dietary Supplements Inner-power for Chemotherapy Induced Fatigue in Breast Cancer
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of dietary supplements Inner-power on chemotherapy induced fatigue in breast cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Brief fatigue inventory (BFI) question 3 (worst level of fatigue)
Key secondary outcomes Global fatigue score and other scores of BFI, Hospital Anxiety and Depression scale (HADS), EORTC QLQ-C30 and minimal clinically important difference (MCID)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Inner-power arm
Inner-power (1pac/day) is administered from Day 1 to Day 21.
Day 1 is the day of the administration of chemotherapy.
Interventions/Control_2 The control arm
Patients only receive the standard chemotherapy.
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) Diagnosed as breast cancer histologically
2) 20 years to 80 years
3) ECOG PS 0-1
4) Patients can answer the questionnaires.
5) Patients are currently under the chemotherapy and are planning to have the same regimen.
6) The fatigue score (BRI q3) was 4 or more in the previous course of the chemotherapy
7) Written consent was obtained
Key exclusion criteria 1) Patients are currently under radiotherapy or interferon therapy
2) Nausea and/or anorexia grades (CTCAE v.4.0) are 3 or more in the previous course of the chemotherapy
3) Uncontrolled anemia
4) Clinically severe heart disease
5) Use of MAO inhibitor and/or central nervous system stimulant
6) Regular use of steroid
7) Mental disorder
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru,IWASE
Organization The Institute of Medical Science, The University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo, JAPAN
TEL 03-3443-8111
Email iwase.office@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name kota KIHARA
Organization NPO JORTC
Division name Operations Office
Zip code
Address 1-5-9-206 Yanaka,Taito-ku,Tokyo, JAPAN
TEL 03-5842-1380
Homepage URL http://www.jortc.jp/
Email info@jortc.jp

Sponsor
Institute Interfaculty Initiative in Information Studies, The University of Tokyo
Department of Palliative Medicine,
The Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 13 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 08 Month 08 Day
Last modified on
2016 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010158

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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