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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004350
Receipt No. R000005179
Scientific Title Radioprotective effects of the Hydrolyzed Rice Bran (HRB) on acute gastroenteritis for cervical cancer treated with chemoradiation
Date of disclosure of the study information 2010/10/18
Last modified on 2016/04/07

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Basic information
Public title Radioprotective effects of the Hydrolyzed Rice Bran (HRB) on acute gastroenteritis for cervical cancer treated with chemoradiation
Acronym Radioprotective effects of HRB on acute gastroenteritis
Scientific Title Radioprotective effects of the Hydrolyzed Rice Bran (HRB) on acute gastroenteritis for cervical cancer treated with chemoradiation
Scientific Title:Acronym Radioprotective effects of HRB on acute gastroenteritis
Region
Japan

Condition
Condition cervical cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We conduct exploratory research into radioprotective effects of HRB on acute gastroenteritis for cervical cancer treated with chemoradiation in a double-blind placebo-controlled trial.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Gastrointestinal disorders
Diarrhea
Nausea
Vomiting
Key secondary outcomes Other gastrointestinal disorders

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Food item: HRB
Time period: 7weeks
Administration method of a drug: oral uptake
Dosage regimen: 3 powders three times a day
Interventions/Control_2 Food item: Placebo
Time period: 7weeks
Administration method of a drug: oral uptake
Dosage regimen: 3 powders three times a day
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
75 years-old >
Gender Female
Key inclusion criteria At study enrollment, patients are required to fulfill all of the following criteria: histologically proven adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma of cervical uterus,
WBC>3500/mm3 , ANC>1500/ mm3 , Hb level>=10.0g/dl, Plt>=100000/mm3,
T-Bil=<1.5dl, AST and ALT<80IU/L,
Cr<1.5mg/dl, CCr>=60ml/min, and provision of written informed consent.
Key exclusion criteria Some of exclusion criteria are as follows: histologically proven small cell carcinoma and sarcoma of cervical uterus, patients planned to be treated with surgery, pregnancy or plans to become pregnant, nursing woman, a past history of allergy to drugs, or ineligibility as determined by the study physicians.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Itoh
Organization Nagoya University Graduate School of Medicine
Division name Therapeutic Radiology
Zip code
Address 65 Tsurumai-cho, Shouwa-ku, Nagoya, Japan
TEL 052-744-2328
Email itoh@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Itoh
Organization Nagoya University Graduate School of Medicine
Division name Therapeutic Radiology
Zip code
Address 65 Tsurumai-cho, Showwa-ku, Nagoya
TEL 052-744-2328
Homepage URL
Email itoh@med.nagoya-u.ac.jp

Sponsor
Institute Department of Radiology,
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Daiwa Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 名古屋大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 18 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 09 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 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
2010 Year 10 Month 07 Day
Last modified on
2016 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005179

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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