UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007814 |
|---|---|
| Receipt number | R000009206 |
| Scientific Title | Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy. |
| Date of disclosure of the study information | 2012/05/02 |
| Last modified on | 2017/11/06 15:37:16 |
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Basic information
Public title
Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy.
Acronym
HGCSG1202
Scientific Title
Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy.
Scientific Title:Acronym
HGCSG1202
Region
| Japan |
Condition
Condition
metastatic or advanced gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of nutritional intervention by elemental diet on improvement in medical treatment results, incidence of digestive organ toxicity, etc. compared with no nutritional intervention in patients with chemotherapy for metastatic or advanced gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to Treatment Failure
Key secondary outcomes
1) Incidence of adverse events (particularly stomatitis incidences, diarrhoea incidence, etc.), 2) Body weight change, 3) Serum albumin change, 4) Relative dose intensity, 5) Safety, 6) Compliance of elemental diet, 7) The number of first-line cycles, 8) response of the tumor, 9) Progression free survival, 10) Overall survival
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
Two packs (600kcal) intake of elemental diet (Elental) is orally performed a day. An administration period makes it every day from the start dates (the first course Day 1) till the end of the first-line treatment. If it is difficult to intake elemental diet because of taking enough food, the calorie per day is deducted 600kcal, as dosing elemental diet per day, from diet meal in advance. Elemental diet continues for two packs in principle. In addition, it is arbitrary about the elemental diet administration after second-line treatment.
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 with histologically proven unresectable progression or relapse gastric cancer.
(2) Patients with the following regimen as first-line treatment,
S-1 + cisplatin, capecitabine + cisplatin, capecitabine + cisplatin + trastuzumab
(3) Patients in whom oral intake of staple food is possible during a study periods
(4) Aged 20 or older
(5) ECOG performance status 0-2
(6) Patients by whom the survival for three months or more is anticipated from the registration.
(7) Written informed consent obtained.
<<laboratory evidence>>
1) Hemoglobin >= 8.0g/dL
2) Neutrophil counts >= 1,000/mm3 or white blood cell counts >= 2,000/mm3
3) Platelet counts >= 75,000 /mm3
4) T-Bil <= 3mg /dL
5) AST or ALT < 150 IU/L
6) Creatinine clearance >= 50 mL/min (it computes based on a Cockcroft-Gault equation).
Key exclusion criteria
(1) Patients who recieved nutritional therapy for one week or more within the past two months
(2) Patient who took L-glutamine quantity content drugs (marzulene, GFO, etc.) for less than two weeks of past.
(3) Patients who are associated with uncontrollable abnormal glucose tolerance
(4) Patients who are associated with critical complications
(5) Pregnancy and lactation, and/or without intention of birth control.
(6) Patients with mental disorders
(7) Patients applicable to contraindications of each use drugs.
(8) Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Komatsu |
Organization
Hokkaido University Hospital
Division name
Department of Cancer Chemotherapy
Zip code
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-5657
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nao Horie |
Organization
Hokkaido University Hospital
Division name
Department of Clinical Trial Management
Zip code
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-7413
Homepage URL
nhorie@med.hokudai.ac.jp
Sponsor or person
Institute
NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO PHARMACEUTICALS 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
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
北海道大学病院、他、HGCSG参加施設ならびに研究協力施設（約30施設）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2012 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009206
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