UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049498 |
|---|---|
| Receipt number | R000056358 |
| Scientific Title | A Randomized Controlled Study of the Out-patient Rehabilitation Intervention following Thoracic Esophageal Cancer Surgery |
| Date of disclosure of the study information | 2022/11/15 |
| Last modified on | 2025/05/17 10:24:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Randomized Controlled Study of the Out-patient Rehabilitation Intervention following Thoracic Esophageal Cancer Surgery
Acronym
A Randomized Controlled Study of the Out-patient Rehabilitation Intervention following Thoracic Esophageal Cancer Surgery
Scientific Title
A Randomized Controlled Study of the Out-patient Rehabilitation Intervention following Thoracic Esophageal Cancer Surgery
Scientific Title:Acronym
A Randomized Controlled Study of the Out-patient Rehabilitation Intervention following Thoracic Esophageal Cancer Surgery
Region
| Japan |
Condition
Condition
Thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a multicenter,prospective trial of an outpatient rehabilitation intervention for patients diagnosed with thoracic esophageal cancer and discharged from the hospital after perioperative cancer rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Shuttle Walking Test (SWT) distance at 3 months from discharge (T4)
Key secondary outcomes
1) Participation rate of outpatient rehabilitation intervention, diary entries and collection rate for Group A
2) Percentage of Group A reaching intervention goals (percentage of weeks in which prescribed strength training was performed at least 2 days per week, percentage of weeks in which target number of steps was achieved at least 5 days per week)
3) Incidence of serious adverse events in group A
4) The following items in groups A and B at 3 months (T4), 6 months (T5), and 12 months (T6) after discharge
Motor function (SWT distance, grip strength, 5 times chair stand test, physical activity)
Skeletal muscle mass (measured by CT), diagnostic criteria for sarcopenia
Nutritional status (body weight, CONUT (total lymphocyte count, Alb, TC))
Functional assessment of the elderly (G8)
Quality of life (EORTC-QLQ-C30)
Utilization of medical resources (cumulative length of hospital stay)
Serious adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Outpatient rehabilitation guidance available
(3 months)
Interventions/Control_2
No outpatient rehabilitation guidance
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) Written consent is obtained from the
patient.
2) The patient is scheduled to undergo
radical open thoracotomy for thoracic
esophageal cancer.
3) Patients must be at least 20 years old and less than 80 years old.
4) PS of 0 or 1.
5) Organ function is preserved.
6) Able to make outpatient visits after
surgery.
7)Blood samples and assay results must meet all of the following conditions (laboratory tests must be performed within 14 days prior to the date of case enrollment)
Key exclusion criteria
1) Patient has an infectious disease requiring systemic treatment.
2) Has a fever of 38 degrees or higher.
3) Pregnant, possibly pregnant, or lactating female patients.
4) Patients with psychosis or concomitant psychiatric symptoms that would preclude participation in the study.
5) Receiving continuous systemic administration (oral or intravenous) of steroids.
6) Patient has uncontrolled diabetes mellitus (HbA1c > 8%).
7) Patient has uncontrolled hypertension.
8) Complicated with unstable angina pectoris (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within 6 months.
9) Complicated interstitial pneumonia, pulmonary fibrosis, severe emphysema, or acute heart failure.
10) Has a history of cerebrovascular disease (e.g., cerebral infarction, intracerebral hemorrhage, transient ischemic attack) occurring within 6 months.
11) Has an active overlapping cancer.
12) Other patients deemed by the treating physician to be unsuitable for enrollment in this clinical trial.
Target sample size
153
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
hs8401@5931.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
| 2022 | Year | 11 | Month | 15 | 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
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 01 | 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
| 2022 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056358
