UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045307 |
|---|---|
| Receipt number | R000050692 |
| Scientific Title | Outpatient rehabilitation for esophageal cancer patients after esophagectomy |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2023/02/07 19:08:09 |
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Basic information
Public title
Outpatient rehabilitation for esophageal cancer patients after esophagectomy
Acronym
Outpatient rehabilitation for esophageal cancer patients after esophagectomy
Scientific Title
Outpatient rehabilitation for esophageal cancer patients after esophagectomy
Scientific Title:Acronym
Outpatient rehabilitation for esophageal cancer patients after esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial of the effects of nutritional intervention and rehabilitation on the suppression of quadriceps isometric strength decline in esopahegal cancer patients after esophagectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in quadriceps isometric strength 3 months after discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Outpatient rehabilitation according to the protocol for 3 months after discharge
Interventions/Control_2
Standard care
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
1) Age, 20 years old or older and 80 years old or younger
2) Histologically diagnosed as esophageal cancer or esophagogastric junction cancer.
3) Stage I-III Esophageal cancer.
4) Planed to resection.
5) Patients who can walk independently at discharge
6)Patients who gained consent to participate in research
Key exclusion criteria
1) With another active cancer.
2) With history of treatment for esophageal cancer (excluding endoscopic treatment).
3) Emergency surgery.
4) Not curative resection.
5) With activity restrictions
6) Taking insulin and warfarin.
7) Unable to obtain appropriate consent due to dementia, mental illness or psychiatric symptoms.
8)Patients who take hypnotic with muscle relaxant effect
9)Inappropriate for participating
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiki |
Organization
Kitasato University
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0375
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
nhiki@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Niihara |
Organization
Kitasato University
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0375
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
mniihara@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital
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
Kitasato Unversity Medical Ethics Organization (KMEO)
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8111
rinri@med.kitasato-u.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
| 2021 | Year | 08 | Month | 31 | 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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050692
