UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021093
Receipt number R000024331
Scientific Title Effect of elemental diet on prognosis in patients with unresectable pancreatic cancer receiving chemotherapy (Observational study)
Date of disclosure of the study information 2016/02/19
Last modified on 2016/02/25 20:12:20

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Basic information

Public title

Effect of elemental diet on prognosis in patients with unresectable pancreatic cancer receiving chemotherapy (Observational study)

Acronym

Effect of elemental diet in patients with unresectable pancreatic cancer

Scientific Title

Effect of elemental diet on prognosis in patients with unresectable pancreatic cancer receiving chemotherapy (Observational study)

Scientific Title:Acronym

Effect of elemental diet in patients with unresectable pancreatic cancer

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify whether elemental diet effects on prognosis in patients receiving chemotherapy for unresectable pancreatic cancer, focusing on nutrition status and adherence to chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Adherence to chemotherapy
2. Adherence to elemental diet
3. Gastrointestinal symptoms
4. Change in nutrition status: body weight, WBC, Total protein, albumin, glucose, HbA1c, cholesterol, triglyceride, cholinesterase, CRP
5. Change in sarcopenia

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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 pancreatic cancer, and who gave a consent to participate in the study.

Key exclusion criteria

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

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teru Kumagi

Organization

Ehime University Hospital

Division name

Gastroenterology

Zip code


Address

454 Shitsukawa, To-on, Ehime

TEL

089-960-5308

Email

terukuma@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teru Kumagi

Organization

Ehime University Hospital

Division name

Gastroenterology

Zip code


Address

454 Shitsukawa, To-on, Ehime

TEL

089-960-5308

Homepage URL


Email

terukuma@m.ehime-u.ac.jp


Sponsor or person

Institute

Ehime University Hospital

Institute

Department

Personal name



Funding Source

Organization

Ajinomoto Pharmaceuticals Co., Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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

松山赤十字病院


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 19 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

2016 Year 01 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: observation study
Eligible patients: patients diagnosed with pancreatic cancer at Ehime University Hospital or Matsuyama Red Cross Hospital by April 30, 2016.

The following variables will be observed while the patients are receiving chemotherapy and Elental.

1. Laboratory data
At diagnosis
CBC, PT, T.Prot, Alb, T.Bil, AST, ALT, LDH, ALP, GGT, ChE, BUN, Cr, eGFR, UA, Na, K, Cl, Ca, Amylase, Lipase, CRP, T.Chol, TG, HDL-c, LDL-c, BS, HbA1c, CEA, CA19-9, DUPAN-2, SPAN-1, routine urinary test

Pre-chemotherapy, periodically every 3-4 weeks
CBC, Alb, T.Bil, AST, ALT, ALP, GGT, ChE, BUN, Cr, eGFR, Amylase, Lipase, CRP, TG, HDL-c, LDL-c, BS, HbA1c, CEA, CA19-9, DUPAN-2, SPAN-1

2. Imaging
At diagnosis
ECG, chest xray, abdominal US, abdominal CT, MRCP, EUS, biopsy, PET-CT

Abdominal CT
every 2 months

3. Diary
adherence to medication, body weight, gastrointestinal symptoms

4. Physical measurement
grip force


Management information

Registered date

2016 Year 02 Month 18 Day

Last modified on

2016 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024331


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name