UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034505 |
|---|---|
| Receipt number | R000039340 |
| Scientific Title | Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy. |
| Date of disclosure of the study information | 2018/10/16 |
| Last modified on | 2021/04/17 09:14:41 |
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Basic information
Public title
Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Acronym
Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Scientific Title
Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Scientific Title:Acronym
Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of skeletal muscle mass during neoadjuvant chemotherapy
Key secondary outcomes
The incidence of postoperative complications.
The incidence of adverse events of chemotherapy.
The change of CGA, body composition, body function, and QOL before chemotherapy, after chemotherapy, after surgery, and 1 year after surgery.
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
| Food | Behavior,custom |
Interventions/Control_1
Taking exercise with Power Plate for 10 days of the every neoadjuvant chemotherapy course.
Nutritional intervention by the amino acid intake after exercise.
Interventions/Control_2
No exercise and no nutritional intervention.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) the subjects aged 65 years or older with thoracic esophageal squamous cell carcinoma who will be intended to take surgery.
2) the subjects treated with neoadjuvant chemotherapy.
3) the subjects with written informed consent.
4) the subjects with the ability to intake amino acid (not necessarily oral intake, but also intake with feeding tube).
Key exclusion criteria
1) the subjects with effort angina, chronic heart failure and tachyarrhythmia.
2) the subjects with chronic respiratory failure.
3) the subjects not able to walk by themselves (ECOG-PS>=3).
4) the subjects with chronic kidney disease.
5) the subjects with severe hepatic dysfunction.
6) the subjects not able to take exercise.
7) the subjects with uncontrolled multiple primary cancer.
8) the subjects judged by the investigator to be unfit to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yamasaki |
Organization
Department of Gastroenterological Surgery
Graduate School of Medicine
Osaka University
Division name
Department of Gastroenterological Surgery Graduate School of Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL
06-6879-3251
myamasaki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Matsuura |
Organization
Department of Gastroenterological Surgery Graduate School of Medicine Osaka University
Division name
Department of Gastroenterological Surgery Graduate School of Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
nmatsuura11@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka General Medical Center
Tottori University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Department of Mrdical Innovation
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-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
大阪大学（大阪府）
大阪急性期・総合医療センター（大阪府）
鳥取大学医学部（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 16 | 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
60
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
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | 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 | 10 | Month | 15 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039340
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