UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012598 |
|---|---|
| Receipt number | R000014733 |
| Scientific Title | The effect of oral nutritional supplement (ONS) on the prognostic nutritional index (PNI) during neoadjuvant chemotherapy for gastric cancer |
| Date of disclosure of the study information | 2013/12/17 |
| Last modified on | 2013/12/16 18:26:56 |
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Basic information
Public title
The effect of oral nutritional supplement (ONS) on the prognostic nutritional index (PNI) during neoadjuvant chemotherapy for gastric cancer
Acronym
The effect of ONS on the PNI during neoadjuvant chemotherapy for gastric cancer
Scientific Title
The effect of oral nutritional supplement (ONS) on the prognostic nutritional index (PNI) during neoadjuvant chemotherapy for gastric cancer
Scientific Title:Acronym
The effect of ONS on the PNI during neoadjuvant chemotherapy for gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the impact of the nutritional intervention with enteral nutrients on the PNI in patients receiving neoadjuvant chemotherapy for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The rate of patients with a decrease in the PNI during neoadjuvant chemotherapy
Key secondary outcomes
(1) Nutritional status
(2) Body weight and body mass index
(3) Performance status
(4) Feasibility of neoadjuvant chemotherapy
(5) Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In addition to a meal, an enteral nutrient (Racol®NF) is administered 3 times per day (600 kcal / day) from the first day of chemotherapy to one day before the operation.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically confirmed gastric cancer
(2) cT2-cT4b tumors with two or more lymph node of greater than 8 mm in minor axes
(3) No peritoneal metastasis with laparoscopic confirmation
(4) An age of 20-80
(5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
(6) Sufficient function of the liver, kidney and bone marrow
(7) Sufficient oral intake
(8) Written informed consent
Key exclusion criteria
(1) Body mass index of < 30
(2) Severe bowel obstruction
(3) Short-bowel syndrome
(4) Severe liver or renal dysfunction
(5) Uncontrolled diabetes mellitus
(6) Congenital amino acid abnormalities
(7) Milk protein allergy or soy protein allergy
(8) Electrolyte abnormalities
(9) Pregnancy or insufficient contraception
(10) Severe mental disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Takayama, MD |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
840 Shijo-Cho, Kashihara, 634-8522, Japan
TEL
0744-29-8863
t-taka@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Takayama, MD |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
840 Shijo-Cho, Kashihara, 634-8522, Japan
TEL
0744-29-8863
Homepage URL
t-taka@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
奈良県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2013 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014733
