UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The usefulness of body weight loss program in patients with cancer
Title of the study (Brief title)	The usefulness of body weight loss program in patients with cancer
Region	Japan

Condition
Condition	The obesity patients with gastric cancer and colon cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of body weight loss program in cancer patiens with obesity
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of body weight loss The rate of complication
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Pre-operative low calorific food exercise 30 Days
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	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Over 28 BMI Early cancer patients Exercise and Pre-operative low calorific food Informed concent
Key exclusion criteria	1. Severe complication 2. IBD 3. Easy bleeding 4. Varix 5. Pregnant 6. Without phycological disorder 7. Dependence on alcohol
Target sample size	30

Research contact person
Name of lead principal investigator	Mitsuo Shimada
Organization	Tokushima University
Division name	Department of Surgery
Address	3-18-15 Kuramoto-cho Tokushima
TEL	088-633-9698
Email	yoshikawa.kozo@tokushima-u.ac.jp

Public contact
Name of contact person	Kozo Yoshikawa
Organization	Tokushima University
Division name	Digestive Surgery
Address	3-18-15 Kuramoto-cho Tokushima
TEL	088-633-9698
Homepage URL
Email	yoshikawa.kozo@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
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)

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	2017 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 23 Day
Last modified on	2017 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030188