UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036094 |
|---|---|
| Receipt number | 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 | 2021/03/09 16:58:54 |
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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 | 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
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
raito.asaoka@icloud.com
Sponsor or person
Institute
Department of gastrointestinal Surgery, Graduate School of Medicine, The university of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041118
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