UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033125 |
|---|---|
| Receipt number | R000037738 |
| Scientific Title | A randomized phase II study to evaluate the prolonged home enteral nutrition for patients after curative esophagectomy |
| Date of disclosure of the study information | 2018/06/25 |
| Last modified on | 2019/12/25 09:23:56 |
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Basic information
Public title
A randomized phase II study to evaluate the prolonged home enteral nutrition for patients after curative esophagectomy
Acronym
Prolonged HEN
Scientific Title
A randomized phase II study to evaluate the prolonged home enteral nutrition for patients after curative esophagectomy
Scientific Title:Acronym
Prolonged HEN
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the superiority of prolonged home enteral nutrition after curative esophagectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Weight loss of more than 10% (24 weeks after surgery)
Key secondary outcomes
1) Change rate of QOL score, 2) Readmission rate, 3) Incidence of an adverse event (associated with home enteral nutrition), 4) Length of indwelling a feeding jejunostomy tube, 5) Adherence rate of protocol treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Supplemental home enteral nutrition (at least 300 kcal / day or more) is continued up to 8 weeks after curative esophagectomy,
Interventions/Control_2
Supplemental home enteral nutrition (at least 300 kcal / day or more) is continued up to 24 weeks after curative esophagectomy,
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) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) Surgery approached from the neck, chest and abdomen, 4) R0 resection with D2 dissection, 5) Tube jejunostomy was constructed at the esophagectomy, 6) >20 and <80 y.o., 7) ECOG-PS 0 or 1, 8) No history of surgery for esophageal cancer, 9 ) No history of chemotherapy or radiotherapy, 10) a) WBC >2000 and <10000/mm3, b) PLT >50000/mm3, c) AST <100 IU/L, ALT <100IU/L, d) T-Bil <2.0 g/dl, e) Cre <1.5mg/dl, 11) Written consent
Key exclusion criteria
1) BMI <17.0 or >30.0, 2) Excision of other organs excluding stomach or gall bladder, 3) Active double cancer, 4) Pregnancy or breast-feeding, 5) Psychosis or mental symptoms, 6) Systemic administration of steroids, 7) History of myocardial infarction or unstable angina, 8) Poorly controlled hypertension, 9) Poorly controlled diabetes, 10) Respiratory disease requiring sustained oxygen therapy.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kamei |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okamoto |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7214
Homepage URL
hi-ok@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
University grants of Tohoku University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575, JAPAN
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 25 | 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 | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037738
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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