UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of gum chewing and/or early oral intake on bowel function recovery after surgery of gynecological cancer patients: a randomized control trial
Title of the study (Brief title)	The effect of gum chewing and/or early oral intake on bowel function recovery
Region	Japan

Condition
Condition	Gynecological cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Bowel function recovery after surgery of gynecological cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of ileus
Key secondary outcomes	First flatus time First defecation time

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Gum chewing
Interventions/Control_2	Non-gum chewing
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	Female
Key inclusion criteria	PS: 0-1 Neutrophils>2000/mm3 Hb>9.0g/dl Plt>100000/mm3 AST,ALT<100U/L T-Bil<1.5mg/dl Cre<1.5mg/dl
Key exclusion criteria	Bowel inflammatory disease History of RT Case with bowel resection Difficulty in mastication
Target sample size	160

Research contact person
Name of lead principal investigator	Soshi Kusunoki
Organization	Juntendo University Faculty of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	0338133111
Email	skusuno@juntendo.ac.jp

Public contact
Name of contact person	Soshi Kusunoki
Organization	Juntendo University Faculty of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	0338133111
Homepage URL
Email	skusuno@juntendo.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine
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	順天堂大学医学部附属順天堂医院（東京都）、順天堂大学医学部附属練馬病院（東京都）、順天堂大学医学部附属浦安病院（千葉県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 03 Day
Anticipated trial start date	2018 Year 05 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	2018 Year 04 Month 02 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036575