UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025557 |
|---|---|
| Receipt number | R000029384 |
| Scientific Title | Randomized study of comparing propylactic antibiotics with enteral nutrition and synbiotics for reducing adverse events during neoadjuvant chemotherapy in patients with esophageal cancer |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2022/07/13 11:39:11 |
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Basic information
Public title
Randomized study of comparing propylactic antibiotics with enteral nutrition and synbiotics for reducing adverse events during neoadjuvant chemotherapy in patients with esophageal cancer
Acronym
Comparing propylactic antibiotics with enteral nutrition and synbiotics during neoadjuvant chemotherapy
Scientific Title
Randomized study of comparing propylactic antibiotics with enteral nutrition and synbiotics for reducing adverse events during neoadjuvant chemotherapy in patients with esophageal cancer
Scientific Title:Acronym
Comparing propylactic antibiotics with enteral nutrition and synbiotics during neoadjuvant chemotherapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of prophyractic antibiotics with enteral nutrition and synbiotics in reducing adverse events during neoadjuvant chemotherapy in patients with esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of febrile neutropenia
Key secondary outcomes
Incidence of adverse events, fecal microbiota, fecal organic acid concentration, postoperative complications
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Levofloxacin
Interventions/Control_2
RACOL-NF
Yakult BL Seichoyaku
galactoorigosaccharides
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. Patients with histologically confirmed primary esophageal cancer, who are scheduled to receive neoadjuvant chemotherapy
2. Performance status is 0-1
3. Dysphagia score is 0-2
4. No serious abnormality in heart, lung, bone marrow, liver, and renal functions
Key exclusion criteria
1. Synchronous or metachronous (within 5 years) malignancy
2. Uncontrolleddiabetes mellitus
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Yano |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Surgery
Zip code
537-0025
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
yano-ma@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Keijiro |
| Middle name | |
| Last name | Sugimura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Surgery
Zip code
537-0025
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
Homepage URL
sugimura-ke@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
Osaka Medical Center for Cancer and Cardiovascular Diseases
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
Tel
06-6972-1181
matsumotochi@opho.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 06 | 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
| 2016 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
