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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004984
Receipt No. R000005924
Scientific Title Randomized phase II study of clinical impact of ghrelin in esophageal cancer patients with cisplatin-based chemotherapy.
Date of disclosure of the study information 2011/01/31
Last modified on 2012/03/26

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Basic information
Public title Randomized phase II study of clinical impact of ghrelin in esophageal cancer patients with cisplatin-based chemotherapy.
Acronym Ghrelin for esophageal cancer patients with chemotherapy
Scientific Title Randomized phase II study of clinical impact of ghrelin in esophageal cancer patients with cisplatin-based chemotherapy.
Scientific Title:Acronym Ghrelin for esophageal cancer patients with chemotherapy
Region
Japan

Condition
Condition patients with advanced esophageal cancer, undergoing chemotherapy
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate whether exogenous ghrelin administration was effective for the treatment to oral intake in esophageal cancer patients with cisplatin-based chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral intake calories
Key secondary outcomes appetite (VAS)
adverse events
hormone measurement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Prospective randomized, placebo-controlled clinical trial assigned a total of 20 patients with thoracic esophageal cancer undergoing radical surgery, into either ghrelin (n=10) or placebo group (n=20). In ghrelin group, synthetic human ghrelin (3 micro g/kg) was administered intravenously repeated bid for 7 days during chemotherapy.
Interventions/Control_2 In placebo group, saline was administered intravenously repeated bid for 7 days during 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 Male and Female
Key inclusion criteria 1) with advanced esophageal cancer undergoing cisplatin-based chemotherapy.
2) age; 20-80 years,
3) enable to adequate oral intake
4) provision of written informed consent.
Key exclusion criteria Patients ineligible for inclusion were those with severe co morbid conditions,
other active malignancy.
Patients in this study had no obstruction by tumor, adequate oral intake, and no severe weight loss.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki
Organization Graduate School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery, Department of Surgery
Zip code
Address 2-2, E2, Yamadaoka, Suita, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Hiura
Organization Graduate School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery, Department of Surgery
Zip code
Address 2-2, E2, Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Homepage URL
Email yhiura@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2011 Year 01 Month 31 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
2010 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 31 Day
Last modified on
2012 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005924

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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