UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018349 |
|---|---|
| Receipt number | R000021239 |
| Scientific Title | Prospective study on the effectiveness of enhanced preoperative rehabilitation programs for patients with esophageal cancer |
| Date of disclosure of the study information | 2015/07/18 |
| Last modified on | 2019/12/01 09:28:16 |
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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
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
kitadani@wakayama-med.ac.jp
Sponsor or person
Institute
2nd department of surgery,Wakayama medical university,School of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021239
