UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026705
Receipt number R000030404
Scientific Title Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.
Date of disclosure of the study information 2017/05/01
Last modified on 2019/10/01 22:38:14

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Basic information

Public title

Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.

Acronym

DiCON study

Scientific Title

Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.

Scientific Title:Acronym

DiCON study

Region

Japan


Condition

Condition

advanced esophageal and gastric cancer

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate appropriate amount of oral nutritional supplement(ONS) to keep body weight for patients with advanced esophageal and gastric cancer who needs systemic chemotherapy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in the ratio of prealbumin before and after administration of ONS

Key secondary outcomes

Compliance of ONS, Changes in the ratio of various nutritional index before and after administration of ONS


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

only Diet Counseling

Interventions/Control_2

administration ONS once a day for 14 days

Interventions/Control_3

administration ONS twice a day for 14 days

Interventions/Control_4

administration ONS three times a day for 14 days

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)advanced gastric cancer or esophageal cancer
2)patients who plans 1st line chemotherapy or chemoradiotherapy
3)patients who can eat more than 50%
4)An age of over 20
5)PS ECOG performance status score 0-1
6)Major organs are in normal conditions in 14 days of administration
neutrophil count => 1,500/mm3
Hemoglobin => 8.0g/dL
Platelet count => 100,000/mm3
Serum bilirubin <= 1.5 mg/dL
AST<=100 IU/L
ALP<=100 IU/L
Serum creatinine <= 2.0 mg/dL
Written informed consent must be taken by patients

Key exclusion criteria

1)ileus or subileus symptom
2)Active infectious diseases(except local infection)
3)massive ascites
4)weight loss more than 10%
5)plans triplet chemotherapy for 1st line chemotherapy
6)allergy for ONS
7)Uncontrollable DM
8)Pregnant or lactation women, or women with the possibility of the pregnancy
9)need systemic steroid therapy
10)Severe mental disorders, neurological disease
11)Dementia
12)Patients who are judged inappropriate for the entry into this study by the investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Ichimura

Organization

Cancer Institute Hospital

Division name

Gastroenterological Chemotherapy Department

Zip code

1358550

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550

TEL

03-3520-0111

Email

takashi.ichimura@jfcr.or.jp


Public contact

Name of contact person

1st name Yukiko
Middle name
Last name Izawa

Organization

Cancer Institute Hospital

Division name

Department of Nutrition

Zip code

1358550

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550

TEL

03-3520-0111

Homepage URL


Email

yukiko.izawa@jfcr.or.jp


Sponsor or person

Institute

Cancer Institute Hospital
Gastroenterological Chemotherapy Department

Institute

Department

Personal name



Funding Source

Organization

Cancer Institute Hospital
Gastroenterological Chemotherapy Department

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

clinico corporation


IRB Contact (For public release)

Organization

Cancer Institute Hospital

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550

Tel

03-3570-0210

Email

med.shinsa@jfcr.or.jp


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

2017 Year 05 Month 01 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

Completed

Date of protocol fixation

2017 Year 03 Month 09 Day

Date of IRB

2017 Year 06 Month 01 Day

Anticipated trial start date

2017 Year 07 Month 25 Day

Last follow-up date

2019 Year 10 Month 01 Day

Date of closure to data entry

2019 Year 10 Month 01 Day

Date trial data considered complete

2019 Year 10 Month 31 Day

Date analysis concluded

2019 Year 12 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 26 Day

Last modified on

2019 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name