UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032246 |
|---|---|
| Receipt number | R000036344 |
| Scientific Title | A Feasibility study of an Out-patient Rehabilitation Intervention for the Postoperative Patients with Thoracic Esophageal Cancer Surgery |
| Date of disclosure of the study information | 2018/04/14 |
| Last modified on | 2022/10/18 20:12:24 |
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Basic information
Public title
A Feasibility study of an Out-patient Rehabilitation Intervention
for the Postoperative Patients with Thoracic Esophageal Cancer Surgery
Acronym
A Feasibility study of an Out-patient Rehabilitation Intervention
for the Postoperative Patients with Thoracic Esophageal Cancer Surgery
Scientific Title
A Feasibility study of an Out-patient Rehabilitation Intervention
for the Postoperative Patients with Thoracic Esophageal Cancer Surgery
Scientific Title:Acronym
A Feasibility study of an Out-patient Rehabilitation Intervention
for the Postoperative Patients with Thoracic Esophageal Cancer Surgery
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerability and safety of outpatient rehabilitation intervention in thoracic esophageal cancer patients who underwent perioperative cancer rehabilitation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of participation in outpatient rehabilitation
Key secondary outcomes
1. Occurrences of events with limited
tolerability for outpatient
rehabilitation interventions
2. Safety
3. Rationales for nonparticipation/
withdrawal
4. Journal entry and collection rates
until three months after discharge (T4 point)
5. Achievement status of intervention
goals
1) Percentage of weeks in which the
prescribed muscle training regimen has
been performed on two or more days
2) Percentage of weeks in which the
target number of steps has been reached
on five or more days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Out-patient Rehabilitation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary enrollment
1) Scheduled to undergo radical
thoracotomy/laparotomy (including
endoscopic surgery) for thoracic
esophageal cancer
2) Written informed consent for primary
enrollment
3) Aged 20-80 years
4) Eastern Cooperative Oncology Group
performance status of 0 or 1
5) Sufficient organ function
Secondary enrollment
1) SWT score has decreased 20% or more
2) Written informed consent for secondary enrollment
3) Without apparent sign of recurrence
4) Scheduled to be discharged within 30
days after radical surgery
5) Without adjuvant therapy
6) Eastern Cooperative Oncology Group
performance status of 0 to 2
7) Sufficient organ function
8) Possible of outpatient visit
Key exclusion criteria
1) Active infection requiring systemic
therapy
2) Fever of 38 degrees or more
3) Pregnancy, possible pregnancy or breastfeeding
4) Psychiatric disease
5) Patients requiring systemic steroid
medication
6) Poorly controlled diabetes mellitus
7) Poorly controlled hypertension
8) Unstable angina within 3 weeks or with a history of myocardial infarction within 6 month
9) Severe pulmonary pneumonitis,
fibrosis, emphysema or heart failure
10) history of cerebral vascular disorder (cerebral infarction, intracerebral
hemorrhage, transient ischemic attack,
etc.) within 6 month
11) Synchronous active malignancies
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sato |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterological Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-shi, Saitama, JAPAN
TEL
042-984-4111
hs8401@5931.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Miyawaki |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterological Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-shi, Saitama, JAPAN
TEL
042-984-4111
Homepage URL
miyawaki@saitama-med.ac.jp
Sponsor or person
Institute
Japanese Association of Supportive Care
in Cancer
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and
Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
CCRI, Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka-shi, Saitama, JAPAN
Tel
042-984-4523
chikens@saitama-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
| 2018 | Year | 04 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036344
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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