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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036094
Receipt No. R000041118
Scientific Title The effect of Multidisciplinary Perioperative REhabilitative Program for esophageal cancer patients undergoing neoadjuvant chemotherapy (M-PREP): Phase I and II study
Date of disclosure of the study information 2019/03/13
Last modified on 2019/03/05

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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
Middle name
Last name Yasuyuki Seto
Organization Graduate School of Medicine, The university of Tokyo
Division name Department of gastrointestinal Surgery
Zip code
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
Middle name
Last name Raito Asaoka
Organization Graduate School of Medicine, The university of Tokyo
Division name Department of gastrointestinal Surgery
Zip code
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 05 Day
Date of IRB
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
2019 Year 03 Month 05 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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