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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048331
Receipt No. 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

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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
Email 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
Email oka-rcgh@okayama-med.jrc.or.p

Sponsor
Institute Department of Gastroenterology, Japanese Red Cross Okayama Hospital
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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