UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006274
Receipt number R000006019
Scientific Title The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancer
Date of disclosure of the study information 2011/10/01
Last modified on 2017/05/16 19:16:32

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Basic information

Public title

The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancer

Acronym

The effects of ONS during chemoradiotherapy in patients with pancreatic and/or esophageal cancer

Scientific Title

The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancer

Scientific Title:Acronym

The effects of ONS during chemoradiotherapy in patients with pancreatic and/or esophageal cancer

Region

Japan


Condition

Condition

Patients with pancreatic and/or esophageal cancer, who are scheduled to receive chemoradiotherapy

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of ONS (Oral Nutritional Supplement) during chemoradiotherapy for patients with pancreatic and/or esophageal cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

To evaluate the effects of Oral Nutritional Supplement (before chemoradiotherapy, 3 weeks after the beginning of chemoradiotherapy and 1 week after chemoradiotherapy) using the Prognostic Nutrition Index (PNI)

Key secondary outcomes

Serum albumin level
Lymphocyte count
Arm circumference(AC)
Triceps subcutaneous fat(TSF)
Body weight and body composition
Amount of food intake
QOL(EORTC QLQ-C30)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

For the interventional group, an amount of 500ml/day of oral nutritional supplement(Ensure)is administered for patients who receive chemoradiotherapy(CRT)This nutrition intervention is performed from the start of chemoradiotherapy to the completion of chemoradiotherapy.

Interventions/Control_2

For the control group, diet therapy alone and oral nutritional supplement(Ensure) is administered after onset of anorexia

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 pancreatic and/or esophageal cancer, who are scheduled to receive chemoradiotherapy
2.Histologically confirmed pancreatic and/or esophageal cancer
3.Patients of age =>20
4.Life expectancy more than 2 months
5.Performance Status: 0-2 (ECOG)
6.Written informed consent

Key exclusion criteria

1.Patients on TPN [total parenteral nutrition]
2.Patients with milk protein allergy
3.Patients with Dysphagia
4.Patients who are judged inappropriate for the entry into the study by the investigater


Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Email

ioka-ta@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Homepage URL


Email

ioka-ta@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology

Institute

Department

Personal name



Funding Source

Organization

Osaka Prefecture

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2011 Year 10 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

Open public recruiting

Date of protocol fixation

2010 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2017 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 02 Day

Last modified on

2017 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name