UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010230 |
|---|---|
| Receipt number | R000011976 |
| Scientific Title | Evaluation of clinical effect of ghrelin on QOL of patients with lung cancer |
| Date of disclosure of the study information | 2013/03/14 |
| Last modified on | 2014/09/13 21:00:18 |
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Basic information
Public title
Evaluation of clinical effect of ghrelin on QOL of patients with lung cancer
Acronym
Evaluation of clinical effect of ghrelin on QOL of patients with lung cancer
Scientific Title
Evaluation of clinical effect of ghrelin on QOL of patients with lung cancer
Scientific Title:Acronym
Evaluation of clinical effect of ghrelin on QOL of patients with lung cancer
Region
| Japan |
Condition
Condition
advanced lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of ghrelin on patients with advanced lung cancer who are receiving platinum-based chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
dietary intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ghrelin
Interventions/Control_2
saline
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
Male and Female
Key inclusion criteria
The eligibility criteria for the study are as follows: 1) histopathologically, or cytopathologically confirmed lung cancer; 2) non-resectable lung cancer; 3) ages 20 to 80 years old; 4) adequate function of major organs; 5) no other active malignancy; 6) an Eastern Cooperative Oncology Group performance status (PS) of 0 or 1; 7) receiving platinum-based chemotherapy; and, 8) povision of written informed consent.
Key exclusion criteria
The exclusion criteria for the study are as follows: 1) pregnant or potentially (willingly) pregnant woman; 2) a past history of other chemotherapy or radiotherappy; and, 3) patients judged to be ineligible by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Nakazato |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Department of Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Department of Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
+81-985-85-2965
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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
| 2013 | Year | 03 | Month | 14 | 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
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 15 | 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
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2014 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011976
