UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008646 |
|---|---|
| Receipt number | 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 09:00:15 |
* 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
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
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/
info@jortc.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.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 |
