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
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
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
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
