UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058416 |
|---|---|
| Receipt number | R000066791 |
| Scientific Title | Evaluation of long-term rehabilitation and nutritional management for tailored medicine after esophageal cancer surgery |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/10 02:01:53 |
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Basic information
Public title
Evaluation of long-term rehabilitation and nutritional management
for tailored medicine after esophageal cancer surgery
Acronym
Evaluation of long-term rehabilitation and nutritional management
for tailored medicine after esophageal cancer surgery
Scientific Title
Evaluation of long-term rehabilitation and nutritional management
for tailored medicine after esophageal cancer surgery
Scientific Title:Acronym
Evaluation of long-term rehabilitation and nutritional management
for tailored medicine after 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 examine the temporal recovery from surgical trauma in patients undergoing surgery for esophageal cancer and to clarify the current effectiveness of outpatient rehabilitation and nutritional interventions, thereby identifying issues and determining the groups requiring active intervention and the appropriate intervention methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Relationship between rehabilitation intervention outcomes and improved nutritional assessment
Key secondary outcomes
1) Compliance rate with rehabilitation
2) Changes in nutritional indicators
3) Identification of groups requiring rehabilitation and nutritional intervention
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
| Maneuver |
Interventions/Control_1
This study aims to clarify how physical performance, body composition analysis, physical activity measured by a pedometer, nutritional intake, and nutritional indicators measured by blood tests change from the start of treatment to one year after surgery.
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
1) The primary tumor is located in the neck, thoracic esophagus, or esophagogastric junction (UICC-TNM 8th edition).
2) Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or basaloid carcinoma.
3) Preoperative adjuvant therapy (chemotherapy, chemoradiotherapy) and curative thoracotomy or laparotomy (including laparoscopic surgery) are planned.
4) Written informed consent has been obtained from the patient.
5) Age 20 years or older and 80 years or younger.
6) Performance status (PS) is 0 or 1.
7) No active concurrent cancer.
8) Organ function is preserved.
Key exclusion criteria
1) If consent to participate in the trial cannot be obtained
2) If regular hospital visits are difficult
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sato |
Organization
Saitama Medical Uniersity International Medical Center
Division name
Gastroenterological surgery
Zip code
3501298
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
+81-42-984-4111
hs8401@5931.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | HIROSHI |
| Middle name | |
| Last name | SATO |
Organization
Saitama Medical Uniersity International Medical Center
Division name
Gastroenterological surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
0429844111
Homepage URL
hs8401@5931.saitama-med.ac.jp
Sponsor or person
Institute
Saiatama Medical University
Institute
Department
Personal name
Hiroshi Sato
Funding Source
Organization
Japan Science and Technology Agency
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
Saitama Medical University International Medical Center Clinical Research IRB
Address
1397-1 Yamane, Hidaka-shi, Saitama
Tel
+81-42-984-4111
imc_irb@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
| 2025 | Year | 07 | Month | 10 | 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
32
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
| 2022 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066791
