Unique ID issued by UMIN | UMIN000006936 |
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Receipt number | R000008199 |
Scientific Title | Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients |
Date of disclosure of the study information | 2011/12/22 |
Last modified on | 2015/09/13 13:24:35 |
Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients
Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients (IP Study)
Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients
Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients (IP Study)
Japan |
Terminal phase of Cancer
Not applicable |
Malignancy
NO
To investigate the efficacy of amino acid jelly in the terminal phase of cancer patients who decreased oral intake.
Efficacy
Exploratory
Pragmatic
Not applicable
Div free survival
The period of nutritional support
The period from the start of nutritional support to death
The period from the start of Div to death
The used amount of EL and IP (caloric intake)
The burden of medical expenses
Level of consciousness (Glasgow Coma Scale)
Health related QOL
Digestive symptoms
Extraneous factors of ingestion
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
3
Treatment
Medicine | Food |
ENSURE LIQUID (EL arm)
Nutritional support using EL starts when a patient's oral intake decreases less than 10% of normal amount of intake.
The intake of foods other than EL is permitted during the nutritional support.
Div support starts when a patient's oral intake decreases less than 125ml/day. The intakes of EL and normal meals are permitted during Div support.
ENSURE LIQUID and Inner Power (EL+ IP arm)
Nutritional support using EL starts when a patient's oral intake decreases less than 10% of normal amount of intake. The intake of foods other than EL is permitted during the nutritional support.
Nutritional support using IP starts when a patient's oral intake of EL or normal meals decreases less than 125ml/day. The intakes of EL and normal meals are permitted during nutritional support using IP.
Div support starts when a patient's oral intake decreases less than 125ml/day. The intakes of EL, IP and normal meals are permitted during Div support.
Inner Power (IP arm)
Nutritional support using IP starts when a patient's oral intake decreases less than 10% of normal amount of intake.
The intake of foods other than IP is permitted during the nutritional support.
Div support starts when a patient's oral intake decreases less than 125ml/day. The intakes of IP and normal meals are permitted during Div support.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who signed a written informed consent
2) Age 20 or older
3) The cancer notification was given
4) Patients who have the cancer that is incurable neither by operation, radiation therapy nor chemotherapy.
5) Patients who are able to orally intake foods.
6) Patients who are expected to survive more than 2 weeks.
7) ECOG PS between 1 to 3
8) Patients who are in the hospital or able to be hospitalized.
1) Patients who are diagnosed as solid carcinoma and have dysphagia
2) Patients who have the problem in cognitive functions
3) Patients who have allergies towards the milk constituents and soy beans
27
1st name | |
Middle name | |
Last name | Hiroto, ISHIKI |
Research Hospital, The Institute of Medical Science, The University of Tokyo
Department of Palliative Medicine
4-6-1, Shirokanedai, Minato-ku, Tokyo, JAPAN
+81-3-3443-8111
ishiki-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Tempei, MIYAJI |
The University of Tokyo
Department of Clinical Trial Data Management, Graduate School of Medicine
7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
03-5800-9086
tmiyaji@m.u-tokyo.ac.jp
Interfaculty Initiative in Information Studies, The University of Tokyo
Department of Palliative Medicine, The University of Tokyo Hospital
Otsuka Pharmaceutical Factory, Inc.
Profit organization
JAPAN
NO
要町病院(東京都)
新座志木中央総合病院(埼玉県)
2011 | Year | 12 | Month | 22 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/25437180
Main results already published
2011 | Year | 05 | Month | 20 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 12 | Month | 22 | Day |
2015 | Year | 09 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008199
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