UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018162 |
|---|---|
| Receipt number | R000021036 |
| Scientific Title | Randomized phase II study of clinical effect of ghrelin administration for DCF with esophageal cancer patients |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2016/07/12 10:17:43 |
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Basic information
Public title
Randomized phase II study of clinical effect of ghrelin administration for DCF with esophageal cancer patients
Acronym
Randomized phase II study of clinical effect of ghrelin administration for DCF with esophageal cancer patients
Scientific Title
Randomized phase II study of clinical effect of ghrelin administration for DCF with esophageal cancer patients
Scientific Title:Acronym
Randomized phase II study of clinical effect of ghrelin administration for DCF with esophageal cancer patients
Region
| Japan |
Condition
Condition
patients with esophageal cancer, undergoing chemotherapy
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and effectiveness of exogenous ghrelin administration for reducing renal toxicity in esophageal cancer patients with DCF.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
serum creatinine level
Key secondary outcomes
adverse events
serum cystatin C level
hormone measurement (ghrelin, growth hormone, Insulin-like growth factor-1)
outcomes of 2nd cycle chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In ghrelin group (n=20), patients with esophageal cancer were recieved intravenous synthetic human ghrelin (0.5 micro g/kg/h) administration for 5 days from a day ago of DCF.
Interventions/Control_2
In control group (n=20), patients with esophageal cancer were received intravenous D-mannitol (178.5 micro g/kg/h) administration for 5 days from a day ago of DCF.
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
1. patients with primary esophageal cancer planned DCF chemotherapy;
2. creatinine clearance > 60 ml/min;
3. No renal disease;
4. no previous treatment;
5. age; 20-80 years;
6. adequate function of major organs;
7. Eastern Cooperative Oncology Group performance status (PS) score of 0 or 1;
8. provision of written informed consent
Key exclusion criteria
1. Patients with severe co morbid conditions
2. other active malignancy
3. judged as inappropriate by physician-in-charge
4. combination with radiation therapy
5. lactation and pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Takiguchi |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
Yamadaoka 2-2 E2, Suita-city, Osaka
TEL
06-6879-3251
stakiguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitomo Yanagimoto |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
Yamadaoka 2-2 E2, Suita-city, Osaka
TEL
06-6879-3251
Homepage URL
yoshitomo-0225@outlook.com
Sponsor or person
Institute
Osaka University School of Medicine Gastroenterological Surgery
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.nature.com/bjc/journal/v114/n12/full/bjc2016160a.html
Number of participants that the trial has enrolled
Results
Blood acyl ghrelin, total ghrelin, and IGF-1 concentrations on day 4 were significantly higher in the ghrelin group. The renal dysfunction, serum creatinine and cystatin C levels, dose reduction, and delay in the initiation of the second cycle of chemotherapy were lower in the ghrelin group than in the control group. Serum creatinine levels were significantly correlated with serum IGF-1 levels.
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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 09 | 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
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2016 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021036
