UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Multidisciplinary Perioperative REhabilitative Program for esophageal cancer patients undergoing neoadjuvant chemotherapy (M-PREP): Phase I and II study
Acronym	The effect of Multidisciplinary Perioperative REhabilitative Program for esophageal cancer patients undergoing neoadjuvant chemotherapy (M-PREP): Phase I and II study
Scientific Title	The effect of Multidisciplinary Perioperative REhabilitative Program for esophageal cancer patients undergoing neoadjuvant chemotherapy (M-PREP): Phase I and II study
Scientific Title:Acronym	The effect of Multidisciplinary Perioperative REhabilitative Program for esophageal cancer patients undergoing neoadjuvant chemotherapy (M-PREP): Phase I and II study
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to clarify the effect of multidisciplinary perioperative rehabilitative program for esophageal cancer patients undergoing neoadjuvant chemotherapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	adherence
Key secondary outcomes	postoperative complications,safety(any compliations associated with rehabilitation).6 minute walk test, hand grip, lower limb strength, pulmonary function, respiratory muscle strength, swallowing function, quality of life, albumin,and prealbumin are measured before chemotherapy, before surgery, and three months after surgery

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Patients undergoing neoadjucvant chemotherapy for advanced esophageal cancer (2)Patients can understand the rehabilitation program and participate with a will of their own. (3)Informed consent for this study is obtained.
Key exclusion criteria	(1)patients with epilepsy, stroke with palsy, Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis or severe heart disease (2)patients with a high risk for falling down (3)patients who cannot perform self training safely (4)patients who are judged by doctors innapropriate to participate in this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Seto
Organization	Graduate School of Medicine, The university of Tokyo
Division name	Department of gastrointestinal Surgery
Zip code	113-8655
Address	7-3-1, Hongou, Bunkyo-ku, Tokyo
TEL	+81-3-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	1st name Yasuyuki Middle name Last name Seto
Organization	Graduate School of Medicine, The university of Tokyo
Division name	Department of gastrointestinal Surgery
Zip code	113-8655
Address	7-3-1, Hongou, Bunkyo-ku, Tokyo
TEL	+81-3-3815-5411
Homepage URL
Email	raito.asaoka@icloud.com

Sponsor
Institute	Department of gastrointestinal Surgery, Graduate School of Medicine, The university of Tokyo
Institute
Department

Funding Source
Organization	Department of gastrointestinal Surgery, Graduate School of Medicine, The university of Tokyo
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Office for Human Research StudiesGraduate School of Medicine and Faculty of Medicine The University of Tokyo
Address	7-3-1 Hongou
Tel	+81338155411
Email	ethics@m.u-tokyo.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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 13 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	Completed
Date of protocol fixation	2019 Year 03 Month 05 Day
Date of IRB	2019 Year 02 Month 21 Day
Anticipated trial start date	2019 Year 03 Month 15 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 04 Month 30 Day

Other
Other related information	We aim this study to claryfy the effect of multidisciplinary perioperative rehabilitative program for esophageal cancer patients undergoing neoadjuvant chemotherapy.

Management information
Registered date	2019 Year 03 Month 05 Day
Last modified on	2021 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041118