UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy
Acronym	The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy
Scientific Title	The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy
Scientific Title:Acronym	The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy
Region	Japan

Condition
Condition	gastric cancer, esophageal cancer, biliary cancer, pancreatic cancer
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to investigate the possibility of improving surgical outcomes and preventing sarcopenia by using prehabilitation and nutritional support during neoadjuvant therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of 6 minutes walk test between before and after neoadjuvant therapy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	The patient with cancer(stomach, esophagus, biliary tract, pancreas) who was planned for neoadjuvant therapy.
Key exclusion criteria	The patient with low ADL who have difficulty in exercising The patient with dementia The patient who may get worse comorbidities or primary diseases by performing exercise therapy. The patient with severe diabetes The patient with gastrointestinal obstruction The patient who are not scheduled for surgery The patient who was judged by the researcher to be inappropriate for this research.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kimitaka Middle name Last name Tanaka
Organization	Hokkaido university hospital
Division name	Department of gastroenterological surgery 2
Zip code	060-8638
Address	Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan
TEL	011-706-7714
Email	kimitaka.t@gmail.com

Public contact
Name of contact person	1st name Kimitaka Middle name Last name Tanaka
Organization	Hokkaido university hospital
Division name	Department of gastroenterological surgery 2
Zip code	060-8638
Address	Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan
TEL	011-706-7714
Homepage URL
Email	kimitaka.t@gmail.com

Sponsor
Institute	Hokkaido University hospital
Institute
Department

Funding Source
Organization	Department of gastroenterological surgery 2, Hokkaido University Faculty of Medicine.
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	Department of gastroenterological surgery 2, Hokkaido univeristy hospital
Address	Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan
Tel	011-706-7714
Email	kimitaka.t@gmail.com

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	2020 Year 06 Month 03 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	Enrolling by invitation
Date of protocol fixation	2020 Year 03 Month 06 Day
Date of IRB	2020 Year 03 Month 23 Day
Anticipated trial start date	2020 Year 06 Month 20 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing special

Management information
Registered date	2020 Year 06 Month 02 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046377

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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