UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019086 |
|---|---|
| Receipt number | R000022049 |
| Scientific Title | The Phase II study of ONS for preventing post-esophagectomy body weight loss in patients with thoracic esophageal cancer |
| Date of disclosure of the study information | 2015/09/21 |
| Last modified on | 2017/11/17 17:33:38 |
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Basic information
Public title
The Phase II study of ONS for preventing post-esophagectomy body weight loss in patients with thoracic esophageal cancer
Acronym
ONS for preventing post-esophagectomy body weight loss
Scientific Title
The Phase II study of ONS for preventing post-esophagectomy body weight loss in patients with thoracic esophageal cancer
Scientific Title:Acronym
ONS for preventing post-esophagectomy body weight loss
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Phase II study to evaluate the safety and efficacy of ONS for preventing post-esophagectomy body weight loss
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of the patients who represent weight loss more than 10% in the postoperative 12 weeks
Key secondary outcomes
incidence and severity of adverse events, the rate of the patients who completed the course, The rate of skeletal muscle loss in postoperative 12 weeks, nutrition index (body weight, BMI, serum albumin level, serum total cholesterol level, total lymphocyte count), QOL score (EORTC QLQ-C30, OES18, DAUGS, EQ-5D-5L), Gait speed (usual and maximum), handgrip strength, arm circumference (cm), triceps skinfolds (cm), calf circumference (cm)
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Take elental for 12 weeks after esophagectomy
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)Histologically confirmed squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma or basaloid carcinoma at endoscopic biopsy.
2)Primary tumor located at thoracic esophagus (UICC7th).
3)Either with or without neoadjuvant chemotherapy.
4)R0 esophagectomy is expected.
5)Aged 20 to 80 years.
6)PS (ECOG) of 0 or 1.
7)Adequate organ function.
8)Written informed consent from patient.
Key exclusion criteria
1)Comorbidities
Confirmed or suspected infection.
Diabetes.
Unstable angina pectoris, or history of myocardial infarction within six months.
Uncontrolable congestive heart failure and arrhythmia
Severe psychiatric disease.
Dialysis patient.
Amino acid metabolic disorder.
Pregnant or possibility of pregnancy.
2)medicine
Continuous systemic steroid therapy.
3)Others
Contraindication to Elental.
Judged by the investigator to be inappropriate for this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Abe |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Kanokoden, Chikusa, Nagoya, Aichi, 464-8681, Japan
TEL
052-762-6111
tabe@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Kawakami |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Kanokoden, Chikusa, Nagoya, Aichi, 464-8681, Japan
TEL
052-762-6111
Homepage URL
j.kawakami@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
愛知県がんセンター中央病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2017 | 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
| 2015 | Year | 09 | Month | 21 | Day |
Last modified on
| 2017 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022049
