UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on the effectiveness of enhanced preoperative rehabilitation programs for patients with esophageal cancer
Acronym	Enhanced preoperative rehabilitation programs for patients with esophageal cancer
Scientific Title	Prospective study on the effectiveness of enhanced preoperative rehabilitation programs for patients with esophageal cancer
Scientific Title:Acronym	Enhanced preoperative rehabilitation programs for patients with esophageal cancer
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is whether the enhanced preoperative rehabilitation program is useful by assessing objective indicators of the body function of pre-operative status.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	reduction of postoperative respiratory complications
Key secondary outcomes	reduction of post-operative all complications, reduction of time until ambulation ,reduction of post-operative hospital stay, improvement of physical functions (CPET, Total psoas area) , improvement of perioperative QOL

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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	enhanced preoperative rehabilitation programs for patients with esophageal cancer
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) The diagnosis of esophageal cancer have been obtained by the histology. The tissue type is not specified. 2) ECOG of Performance Status (PS) is 0-2. 3) The treatment history of esophageal cancer like chemotherapy,radiotherapy and endoscopic treatment is not specified. 4) The dysfunction of lower limb is considered to be difficult to paddle the ergometer. 5) There is no serious complication of the heart and lung that is judged to be difficult to exercise. 6) The informed consent has been obtained.
Key exclusion criteria	1) The complications such as a cardiovascular and cerebral vascular disorders ,respiratory failure have happened. 2) The blood toxicity of Grade4 and Grade3 or more non-blood toxicity after the neoadjuvant chemotherapy and chemoradiotherapy continues. 3) There is a risk of aspiration. 4) The exercise is considered difficult for strong pain in the lower limbs.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Mikihito Middle name Last name Nakamori
Organization	Wakayama Medical University,School of Medicine
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera,,Wakayama641-8510,JAPAN
TEL	073-441-0613
Email	chamcham@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Kitadani Middle name Last name Junya
Organization	Wakayama medical university,School of Medicine
Division name	2nd department of surgery
Zip code	641-8510
Address	811-1,Kimiidera,,Wakayama641-8510,JAPAN
TEL	073-441-0613
Homepage URL
Email	kitadani@wakayama-med.ac.jp

Sponsor
Institute	2nd department of surgery,Wakayama medical university,School of medicine
Institute
Department

Funding Source
Organization	Grants-in-Aid,Scientific Research
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	Clinical research center, Wakayama Medical University
Address	811-1 Kimiidera Wakayama
Tel	073-447-2300
Email	wa-rinri@wakayama-med.ac.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	2015 Year 07 Month 18 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	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 05 Month 20 Day
Anticipated trial start date	2015 Year 07 Month 19 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 18 Day
Last modified on	2019 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021239