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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034505
Receipt No. 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 2019/04/25

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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
Middle name
Last name Makoto Yamasaki
Organization Department of Gastroenterological Surgery
Graduate School of Medicine
Osaka University
Division name Department of Gastroenterological Surgery Graduate School of Medicine
Zip code
Address 2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL 06-6879-3251
Email myamasaki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihiro Matsuura
Organization Department of Gastroenterological Surgery Graduate School of Medicine Osaka University
Division name Department of Gastroenterological Surgery Graduate School of Medicine
Zip code
Address 2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email nmatsuura11@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
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
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
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
2021 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
2018 Year 10 Month 15 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039340

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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