UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028659
Receipt number R000032805
Scientific Title Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Date of disclosure of the study information 2017/08/15
Last modified on 2024/02/02 16:38:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer

Acronym

Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer

Scientific Title

Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer

Scientific Title:Acronym

Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of elemental diet during chemotherapy in patients with unresectable advanced pancreatic cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

overall survival

Key secondary outcomes

Body weight, body composition, Plasma protein, CA 19-9, ECOG PS, QOL, Adverse events and tolerability of chemotherapy, Progression-free survival (PFS), Dietary Intake


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients administered elemental diet (1-2 packs per a day) for 3 month during chemotherapy

Interventions/Control_2

Patients administer chemotherapy without nutritional therapy

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

Patients receiving chemotherapy for unresectable advance pancreatic cancer.
Patients gave a consent to participate in the study.

Key exclusion criteria

1. Age under 20 years
2. Allergy to Elental
3. Sever diabetes
4. Pregnant or breastfeeding women
5. Patients with amino acid disorder
6. Patients whom physician considered unqualifiable

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takuji
Middle name
Last name Iwashita

Organization

Gifu University Hospital

Division name

First Dept. of Internal Medicine

Zip code

501-1194

Address

1-1 Yanagido, Gifu 501-1194

TEL

058-230-6308

Email

takuji@w7.dion.ne.jp


Public contact

Name of contact person

1st name Shinya
Middle name
Last name Uemura

Organization

Gifu University Hospital

Division name

First Dept. of Internal Medicine

Zip code

501-1194

Address

1-1 Yanagido, Gifu 501-1194

TEL

058-230-6308

Homepage URL


Email

ueshin550621@gmail.com


Sponsor or person

Institute

First Dept. of Internal Medicine, Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

First Dept. of Internal Medicine, Gifu University Hospital

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

Gifu University Hospital Independent Ethics Committee

Address

1-1 Yanagido, Gifu

Tel

058-230-6059

Email

gjme00004@jim.gifu-u.ac.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 08 Month 15 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

No longer recruiting

Date of protocol fixation

2017 Year 08 Month 01 Day

Date of IRB

2017 Year 07 Month 05 Day

Anticipated trial start date

2017 Year 08 Month 15 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry

2023 Year 12 Month 01 Day

Date trial data considered complete

2024 Year 06 Month 01 Day

Date analysis concluded

2024 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 14 Day

Last modified on

2024 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name