UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010400 |
|---|---|
| Receipt number | R000012070 |
| Scientific Title | Influence of preoperative vitamin C administration on suppresive effect of oxidative stress in patients with colorectal cancere receiving parenteral nutrition |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2014/04/03 15:25:17 |
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Basic information
Public title
Influence of preoperative vitamin C administration on suppresive effect of oxidative stress in patients with colorectal cancere receiving parenteral nutrition
Acronym
Influence of preoperative vitamin C administration on suppresive effect of oxidative stress in patients with colorectal cancere receiving parenteral nutrition
Scientific Title
Influence of preoperative vitamin C administration on suppresive effect of oxidative stress in patients with colorectal cancere receiving parenteral nutrition
Scientific Title:Acronym
Influence of preoperative vitamin C administration on suppresive effect of oxidative stress in patients with colorectal cancere receiving parenteral nutrition
Region
| Japan |
Condition
Condition
Patients with colorectal cancer who need preoperativ parenteral nutrition
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect of preoperative administration of vitamin C for patients with colorectal cacncer receiving parenteral nutrition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
To estimate the suppresive effect for preoperative administration of vitamin C for patietns with colorectal cancera undergoing surgery.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patietns with administration of preoperative Vit C.
Interventions/Control_2
Patietns without administration of preoperative Vit C.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1: Patients with more than 20 years old.
2: Patients who can get an informed consent from themselves.
Key exclusion criteria
1: Patients with uncontrollable diabetes (blood sugar >= 200mg/dL or urinary ketone positive).
2: Patients with liver dysfunction (The serum levels of AST >=120 IU/L or ALT >=100 IU/L).
3: Patients with renal failure (The serum levels of Cre >= 2mg/dL or BUN >= 40 mg/dL).
4: Patients with congenital abnoramilty of aminoacid metaobolism.
5: Patients with allergy for Vit C.
6: Patients with hemophilia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Ishizuka |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterological Surgery
Zip code
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, 321-0293 JAPAN
TEL
0282-87-2158
mm-ishizuka@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Ishizuka |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterological Surgery
Zip code
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, 321-0293 JAPAN
TEL
0282-87-2158
Homepage URL
mm-ishizuka@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
獨協医科大学病院(栃木県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 02 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 02 | Day |
Last modified on
| 2014 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012070
