UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008020 |
|---|---|
| Receipt number | R000009435 |
| Scientific Title | Effects of nutritional support care in patients receiving outpatient chemotherapy to the colorectal area |
| Date of disclosure of the study information | 2012/05/23 |
| Last modified on | 2014/11/18 19:26:30 |
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Basic information
Public title
Effects of nutritional support care in patients receiving outpatient chemotherapy to the colorectal area
Acronym
Effects of nutritional support care in patients receiving outpatient chemotherapy to the colorectal area
Scientific Title
Effects of nutritional support care in patients receiving outpatient chemotherapy to the colorectal area
Scientific Title:Acronym
Effects of nutritional support care in patients receiving outpatient chemotherapy to the colorectal area
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the nutritional support care effects to the prevention of weight reduction, nutritional status, completion rate of treatment and reduction of adverse events in patients receiving outpatients chemotherapy to the colorectal area.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight reduction rate during the chemotherapy
Key secondary outcomes
Hematology and blood chemistry, (Alb, Pre-Alb, total cholesterol, total lymphocyte count, total protein, CRP, Ghrelin)
Occurrence of adverse event
The ratio of the patients who completed the treatment course
ADL (Activities of Daily Living)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To administrate the ethical liquid enteral nutrition formula (Racol NF) 400kcal per day from the day start chemotherapy to the day complete of the study.
Interventions/Control_2
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 who will receive chemotherapy to the colorectal area
2. Patients who have histologically diagnosed colorectal carcinoma.
3. Patients aged 20 years and older at the time of informed consent.
4. Patients with ECOG performance status of 0 to 2.
5. Patients who not have severe disorder to heart, lung, bone marrow, liver and kidney.
6. Patients without severe complications.
7. Patients and legal representative have given voluntary written informed consent.
Key exclusion criteria
1. Patients with severe narrowing of colon lumen
2. Patients with short-bowel syndrome
3. Patients with severe liver/renal disorder
4. Patients with severe diabetes mellitus (HbA1c >7.0%)
5. Patients with inborn error of amino acid metabolism
6. Patients with allergy to any ingredient of milk.
7. Patients with abnormal electrolyte metabolism
8. Patient s with hemophilia
9. Patients who have received blood transfusion within a month
10. Pregnant women or women
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Kurachi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Second Surgery
Zip code
Address
1-20-1, handayama, higashi-ku, Hamamatu, Shizuoka, 431-3192
TEL
053-435-2279
kurachi1@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Kurachi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Second Surgery
Zip code
Address
1-20-1, handayama, higashi-ku, Hamamatu, Shizuoka, 431-3192
TEL
053-435-2279
Homepage URL
kurachi1@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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)
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
国立大学法人浜松医科大学浜松医科大学医学部附属病院(静岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 23 | Day |
Last modified on
| 2014 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009435
