UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006936
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

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Basic information

Public title

Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients

Acronym

Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients (IP Study)

Scientific Title

Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients

Scientific Title:Acronym

Prospective Exploratory Study to Investigate the Efficacy of Amino Acid Jelly in Cancer Patients (IP Study)

Region

Japan


Condition

Condition

Terminal phase of Cancer

Classification by specialty

Not applicable

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of amino acid jelly in the terminal phase of cancer patients who decreased oral intake.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Div free survival

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

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.

Interventions/Control_2

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.

Interventions/Control_3

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.

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 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.

Key exclusion criteria

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

Target sample size

27


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroto, ISHIKI

Organization

Research Hospital, The Institute of Medical Science, The University of Tokyo

Division name

Department of Palliative Medicine

Zip code


Address

4-6-1, Shirokanedai, Minato-ku, Tokyo, JAPAN

TEL

+81-3-3443-8111

Email

ishiki-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tempei, MIYAJI

Organization

The University of Tokyo

Division name

Department of Clinical Trial Data Management, Graduate School of Medicine

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5800-9086

Homepage URL


Email

tmiyaji@m.u-tokyo.ac.jp


Sponsor or person

Institute

Interfaculty Initiative in Information Studies, The University of Tokyo
Department of Palliative Medicine, The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Otsuka Pharmaceutical Factory, Inc.

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


Email



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

要町病院(東京都)
新座志木中央総合病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25437180

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

Main results already published

Date of protocol fixation

2011 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 08 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

2011 Year 12 Month 22 Day

Last modified on

2015 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008199


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name