UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Acronym	Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Scientific Title	Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Scientific Title:Acronym	Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Region	Japan

Condition
Condition	upper gastrointestinal tract cancers
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of preoperative nutritional counseling and exercise guidance for frail patients with upper gastrointestinal tract cancers aiming to keep their body weight and improve their Nutritional status postoperatively
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of weight loss at six months after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Other
Interventions/Control_1	nutritional counseling exercise guidance
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are going to undergo on operation for upper gastrointestinal tract cancers at Kansai Rosai Hospital 2)Patients who agree in writing
Key exclusion criteria	1) Patients who are difficult to understand the meaning of the counseling 2) Patients who are judged to be unsuitable by the attending physicians
Target sample size	250

Research contact person
Name of lead principal investigator	1st name ATSUSHI Middle name Last name TAKENO
Organization	Kansai Rosai Hospital
Division name	Department of Gastrointestinal Surgery
Zip code	6608511
Address	3-1-69, Inabasou, Amagasaki, Hyogo
TEL	06-6416-1221
Email	takeno-atsushi@kansaih.johas.go.jp

Public contact
Name of contact person	1st name ATSUSHI Middle name Last name TAKENO
Organization	Kansai Rosai Hospital
Division name	Department of Gastrointestinal Surgery
Zip code	6608511
Address	3-1-69, Inabasou, Amagasaki, Hyogo
TEL	06-6416-1221
Homepage URL
Email	takeno-atsushi@kansaih.johas.go.jp

Sponsor
Institute	Kansai Rosai Hospital
Institute
Department

Funding Source
Organization	Kansai Rosai Hospital
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	Kansai Rosai Hospital
Address	3-1-69, Inabasou, Amagasaki, Hyogo
Tel	06-6416-1121
Email	takeno-atsushi@kansaih.johas.go.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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 25 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 05 Month 02 Day
Date of IRB	2020 Year 05 Month 26 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2023 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No

Management information
Registered date	2021 Year 01 Month 23 Day
Last modified on	2021 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049210