UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014335 |
|---|---|
| Receipt number | R000016687 |
| Scientific Title | A study to evaluate the efficacy of theracurmin (highly absorbtive curcumin) for cachexia in treatment-resistant cancer patients |
| Date of disclosure of the study information | 2014/06/22 |
| Last modified on | 2016/06/21 14:15:03 |
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Basic information
Public title
A study to evaluate the efficacy of theracurmin (highly absorbtive curcumin) for cachexia in treatment-resistant cancer patients
Acronym
A study to evaluate the efficacy of theracurmin for cachexia in treatment-resistant cancer patients
Scientific Title
A study to evaluate the efficacy of theracurmin (highly absorbtive curcumin) for cachexia in treatment-resistant cancer patients
Scientific Title:Acronym
A study to evaluate the efficacy of theracurmin for cachexia in treatment-resistant cancer patients
Region
| Japan |
Condition
Condition
treatment-resistant cancer patients
Classification by specialty
| Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of theracurmin (highly absorbtive curcumin) on nutrition status and quality of life (QOL), and to investigate immunological effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
immunological effect
The expression of cytokines
Key secondary outcomes
At before and 30days,60days, and 90days after the administration of theracurmin
1)Nutrition status
2)QOL score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
360mg of theracurmin per day orally for 90 days
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.pathological confirmed cancer patient
2.treatment-resistant advanced cancer patient
3.Oral intake
4.GPS. 0-2
5.No abnormality in digestive organs due to endogenous diseases
Key exclusion criteria
1.Patients who undergo chemotherapy, operation, or radiation
2.Considered inadequate for the inclusion in the study by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Kwakami |
Organization
Keio University School of Medicine
Division name
Institute for Advanced Medical and Science Research
Zip code
Address
Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
0333531211
yutakawa@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Iwata |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
0333531211
Homepage URL
iwatatakashi@1995.jukuin.keio.ac.jp
Sponsor or person
Institute
Institute for Advanced Medical and Science Research
Institute
Department
Personal name
Funding Source
Organization
None
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
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 22 | 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
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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | 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
| 2014 | Year | 06 | Month | 21 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016687
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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