UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047895 |
|---|---|
| Receipt number | R000054597 |
| Scientific Title | Effectiveness of rehabilitation during neoadjuvant chemotherapy on postoperative exercise capacity in patients with esophageal cancer |
| Date of disclosure of the study information | 2022/05/30 |
| Last modified on | 2024/12/02 20:44:05 |
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Basic information
Public title
Effectiveness of rehabilitation during neoadjuvant chemotherapy on postoperative exercise capacity in patients with esophageal cancer
Acronym
Effectiveness of rehabilitation during neoadjuvant chemotherapy on postoperative exercise capacity in patients with esophageal cancer
Scientific Title
Effectiveness of rehabilitation during neoadjuvant chemotherapy on postoperative exercise capacity in patients with esophageal cancer
Scientific Title:Acronym
Effectiveness of rehabilitation during neoadjuvant chemotherapy on postoperative exercise capacity in patients with esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cacner
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate if rehabilitation during NAC for esophageal cancer patients is more effective than rehabilitation after NAC in recovering postoperative exercise capacity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walk distance (6MWD)
Key secondary outcomes
QOL (EORTC QLQ-C30)
Muscle strength (hand grip strength, quadriceps force)
Skeletal muscle mass (PMI)
Fatigue (CFS)
Nutritional Status (GNRI, weight)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[NAC group]
1. Patients who has been diagnosed with esophageal cancer
2. Patients who are scheduled for esophagectomy by standby surgery
3. Patients who started rehabilitation after completion of the first NAC course and before the start of the second NAC course
[Control group]
1. Patients who has been diagnosed with esophageal cancer
2. Patients who are scheduled for esophagectomy by standby surgery
3. Patients who started rehabilitation after 2 NAC course
Key exclusion criteria
[Both group]
1. Patients with cerebrovascular, musculoskeletal disease and cognitive impairment that would affect the performance of the evaluation
2. Patients with complications requiring treatment during chemotherapy and postoperatively
3. Patients with less than 2 courses of NAC
4. Patients who have undergone radiation therapy
5. Patients who have difficulty communicating because they do not understand the purpose of the study
6.Patients who are deemed inappropriate as research subjects by the researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7963
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7963
Homepage URL
ryokozu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital (Clinical Research Ethics Review Committee)
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
長崎大学病院（長崎県）、田上病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 30 | 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
58
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 | 05 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2022 | Year | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054597
