UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of clinical effect of ghrelin administration for DCF with esophageal cancer patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shuji Takiguchi
Organization	Osaka University School of Medicine
Division name	Gastroenterological Surgery
Address	Yamadaoka 2-2 E2, Suita-city, Osaka
TEL	06-6879-3251
Email	stakiguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoshitomo Yanagimoto
Organization	Osaka University School of Medicine
Division name	Gastroenterological Surgery
Address	Yamadaoka 2-2 E2, Suita-city, Osaka
TEL	06-6879-3251
Homepage URL
Email	yoshitomo-0225@outlook.com

Sponsor
Institute	Osaka University School of Medicine Gastroenterological Surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.nature.com/bjc/journal/v114/n12/full/bjc2016160a.html
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021036