UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007441 |
|---|---|
| Receipt number | R000008771 |
| Scientific Title | Pilot study of nutritional intervention by elemental diet for lung cancer during chemotherapy |
| Date of disclosure of the study information | 2012/03/06 |
| Last modified on | 2015/03/07 00:29:22 |
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Basic information
Public title
Pilot study of nutritional intervention by elemental diet for lung cancer during chemotherapy
Acronym
Pilot study of nutritional intervention for lung cancer during chemotherapy
Scientific Title
Pilot study of nutritional intervention by elemental diet for lung cancer during chemotherapy
Scientific Title:Acronym
Pilot study of nutritional intervention for lung cancer during chemotherapy
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of nutritional intervention by elemental diet (Elental) in patieints with chemotherapy for non-small cell lung cancer and small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Decrease ratio of body weight
Key secondary outcomes
Alb, Pre-Alb, Transfferin, QOL, Side effects, Overall survival, Progression free survival, one year survival rate, chemotherapeutical drug, Chemotherapeutical drug compliance
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
We performed nutritional intervention by elemental diet (Elental) in patieints with non-small cell lung cancer and small-cell lung cancer for 16 weeks from first day of the initial chemotherapy.
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)Histologically proven non-squamous non-small cell lung cancer
2)Patient who has measurable lesion by RECIST
3-1)Non-small cell lung cancer: Stage 3B/4 NSCLC
3-2)Small cell lung cancer: extensive small-cell lung cancer
4)ECOG performance status: 0-1
5)Aged>=20 years
6)No chemotherapy, radiotherapy, immunotherapy as prior therapy as for NSCLC
7)Adequate organ functions
WBC>= 4000/mm3 & <= 12000mm3
Neutro>=2000/mm3
Platelet >= 100000/mm3
Hemoglobin>= 9.5g/dL
GOTand GPT< 2.5*the upper limit of normal
Bilirubin<= 2.0mg/dL
Serum creatinine<= 1.2mg/dL or 24hr creatinine clearance> 60mL/min
PaO2>= 60Torr
8)Life expectancy >= 4months
9)Written informed consent"
Key exclusion criteria
"
1)Severe infections
2)Fever of over 38 degrees
3)Serious complications such as cardiac disease, interstitial pneumonia, bleeding diathesis, uncontrollable hypertension or diabetes mellitus
4)History of active double cancer within 5 years
5)Symptomatic brain metastases
6)Pleural effusion or ascites to treat
7)Pericardial effusion
8)Cchickenpox
9)Motor weakness or disorder of peripheral nerve
10)History of drug hypersensitivity
11)Pregnancy
12)History of hypersensitivity against elements of Elental
13)Severe diabetes, and patients suspected abnormal sugar metabolism because of high dosage of steroids
14)Abnormal amino acid metabolism
15)Inappropriate judged by physicians"
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Isobe |
Organization
Toho University Omori Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku Tokyo Japan
TEL
03-3762-4151
kazutoshiisobe@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Isobe |
Organization
Toho University Omori Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku Tokyo Japan
TEL
03-3762-4151
Homepage URL
kazutoshiisobe@aol.com
Sponsor or person
Institute
Toho University
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | 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
| 2012 | Year | 03 | Month | 05 | Day |
Last modified on
| 2015 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008771
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
