UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013133
Receipt No. R000015315
Scientific Title Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Date of disclosure of the study information 2014/03/01
Last modified on 2019/08/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Acronym Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Scientific Title Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Scientific Title:Acronym Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Region
Japan

Condition
Condition locally advanced non-small-cell lung cancer
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 An aim of this study is to confirm incidence of the radiation esophagitis when we used sodium alginate in an early stage or the close for a case to be given lung cancer chemoradiation simultaneous combination therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Esophagitis incidence grade 3 or more based on CTCAE v4.0
Key secondary outcomes responce rate
progression free survival
overall survival
Other adverse events
Use ratio of analgesic
quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 take sodium alginate for start of therapy
Interventions/Control_2 take sodium alginate after symptom onset
Interventions/Control_3 take the water which cooled off to 4 degrees Celsius for start of therapy
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 Histologically or cytologically confirmed non-small-cell lung cancer
Disease stage is IIIA/B period which is available for radical irradiation.
ECOG performance status of 0 or 1
the case that we can ingest
Adequate bone marrow function
WBC 4,000/cmm or more; PLT 100,000/cmm or more
Adequate liver function
T Bil 1.5 mg/dl or less; GOT and GPT 2.5 times the upper limit of normal at each institution
Adequate kidney function
Creatinine 1.5 mg/dl or less; Ccr 60 ml/min or more
Adequate pulmonary function
Pa02 60 Torr or more
However, this will not apply if there is reduced respiratory function due to stenosis of a main bronchus or a lobar bronchus, and it can be expected that resolution of the stenosis will lead to rapid improvement.
Acquisition of written informed consent
Key exclusion criteria the case that esophagus is not included in the fields in radiation treatment planning
the case with atelectasis of the lung unilateral before treatment
the case that has difficulty in oral internal use
the case with serious complications
the case that there is a history of treatment of esophageal cancer and the gastric cancer, and esophageal reconstruction is done
the case with the reflux oesophagitis of the clear activity
Pregnant woman, nursing mother, the women who may be pregnant, the women with the will or the men who hope for fertility with pregnancy
the case that takes sodium alginate
the case (when, however, it can be discontinued for condition possible registration) that takes proton pump inhibitor (PPI) regularly
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Katsuyuki
Middle name
Last name Kiura
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-2357-227
Email kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Kiichiro
Middle name
Last name Ninomiya
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7227
Homepage URL
Email doctor_kirou@hotmail.com

Sponsor
Institute Okayama Lung Cancer Study Group
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Tel 086-235-6938
Email mae6605@adm.okayama-u.ac.jp

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 岡山大学病院(岡山県)
倉敷中央病院(岡山県)
公立学校共済組合 中国中央病院(広島県)
医療法人 住友別子病院(愛媛県)
国家公務員共済組合連合会 呉共済病院(広島県)
岡山赤十字病院(岡山県)
川崎医科大学附属川崎病院(岡山県)
愛媛県立中央病院(愛媛県)
津山中央病院(岡山県)
福山市民病院(広島県)
尾道市民病院(広島県)
鳥取市立病院(鳥取県)
独立行政法人国立病院機構 南岡山医療センター(岡山県)
独立行政法人国立病院機構 四国がんセンター(愛媛県)
独立行政法人国立病院機構 山口宇部医療センター(山口県)
独立行政法人国立病院機構 岡山医療センター(岡山県)
独立行政法人国立病院機構 福山医療センター(広島県)
独立行政法人労働者健康福祉機構 岡山労災病院(岡山県)
独立行政法人労働者健康福祉機構 香川労災病院(香川県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 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 Terminated
Date of protocol fixation
2014 Year 02 Month 11 Day
Date of IRB
2014 Year 03 Month 18 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 11 Day
Last modified on
2019 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.