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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032246
Receipt No. 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 2019/07/10

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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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Sato
Organization Saitama Medical University International Medical Center
Division name Gastroenterological Surgery
Zip code
Address 1397-1 Yamane, Hidaka-shi, Saitama, JAPAN
TEL 042-984-4111
Email hs8401@5931.saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Miyawaki
Organization Saitama Medical University International Medical Center
Division name Gastroenterological Surgery
Zip code
Address 1397-1 Yamane, Hidaka-shi, Saitama, JAPAN
TEL 042-984-4111
Homepage URL
Email miyawaki@saitama-med.ac.jp

Sponsor
Institute Japanese Association of Supportive Care
in Cancer
Institute
Department

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
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

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 Open public 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
2020 Year 04 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 14 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036344

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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