UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048331 |
|---|---|
| Receipt number | R000055086 |
| Scientific Title | Effectiveness of nutrition counselling and physical therapy for patients with pancreatic cancer; a prospective cohort study |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/07/09 22:39:32 |
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Basic information
Public title
Effectiveness of nutrition counselling and physical therapy for patients with pancreatic cancer; a prospective cohort study
Acronym
Effectiveness of nutrition counselling and physical therapy for patients with pancreatic cancer; a prospective cohort study(AOE study3)
Scientific Title
Effectiveness of nutrition counselling and physical therapy for patients with pancreatic cancer; a prospective cohort study
Scientific Title:Acronym
Effectiveness of nutrition counselling and physical therapy for patients with pancreatic cancer; a prospective cohort study(AOE study3)
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of nutrition counselling and physical therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PMI(psoas muscle index) at 3 months or just before the operation compare with historical control
Key secondary outcomes
Compare with historical control below
1.CONUT at 3 months or just before the operation
2.Serum albumin at 3 months or just before the operation
3.HbA1c at 3 months or just before the operation
4.How long days patients could receive chemotherapy or just before the operation
5.Over all survival
6.Body mass index at 3 months or just before the operation
7.How often patients could work out
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
1.previously untreated and histopathologically confirmed pancreatic cancer patients
2.provided written informed consent
Key exclusion criteria
1.severe complication
2.disability of oral intake
3.Inflammatory bowel disease
4.ECOG scale of performance status 3-4
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Harada |
Organization
Japanese Red Cross Okayama Hospital
Division name
Department of Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL
086-222-8811
oka-rcgh@okayama-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Harada |
Organization
Japanese Red Cross Okayama Hospital
Division name
Department of Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL
086-222-8811
Homepage URL
oka-rcgh@okayama-med.jrc.or.p
Sponsor or person
Institute
Department of Gastroenterology, Japanese Red Cross Okayama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Okayama Hospital
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
Tel
086-222-8811
oka-rcgh@okayama-med.jrc.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
岡山赤十字病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 08 | Month | 01 | Day |
Other
Other related information
Single center, open-label, prospective cohort study. Between August 15, 2022, and December 31, 2026, consecutive patients with pancreatic cancer who met inclusion criteria.
Management information
Registered date
| 2022 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055086
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
