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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004483 |
Receipt No. | R000005364 |
Scientific Title | Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers |
Date of disclosure of the study information | 2010/10/31 |
Last modified on | 2013/04/30 |
Basic information | ||
Public title | Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers | |
Acronym | Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers | |
Scientific Title | Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers | |
Scientific Title:Acronym | Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers | |
Region |
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Condition | ||
Condition | esophageal cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to evaluate whether enteral nutrition during chemotherapy for advanced esophageal cancers decreases advere chemotherapy-related adverse side effect and improves immune function |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | frequency of chemotherapy-related adverse effects |
Key secondary outcomes | immune function
nutrition status |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | An amount of 600ml/day of enteral nutritional supplement(Racol@ )is administerd for patients who receive chemotherapy consisting of 5-FU, cisplatin and adriamycin for advanced esophageal cancers are administered.This nutrition intervention is performed for 17 days, from 3 days before the start of chemotherapy to 7 days after the completion of chemotherapy. | |
Interventions/Control_2 | Total parenteral nutrition support is administerd for patients who underoing the same chemotherapy during chemotherapy, in place of enteral nutrition support. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who have primary esophageal cancer which is histologically confirmed
-Performance status is 0-2 -No serious abnormality in heart, lung, bone marrow, liver, and renal functions -obtain informed consent |
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Key exclusion criteria | Patients who have:
-narrowing of esophago-intestinal lumen -Serious milk allergy -Serious abnormality in liver and renal |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medicine, Osaka University | ||||||
Division name | Department of Gastroenterological Surgery | ||||||
Zip code | |||||||
Address | 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan | ||||||
TEL | +81-6-6879-3251 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Graduate School of Medicine, Osaka University | ||||||
Division name | Department of Gastroenterological Surgery | ||||||
Zip code | |||||||
Address | 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan | ||||||
TEL | +81-6-6879-3251 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Graduate School of Medicine, Osaka University, Department of Gastroenterological Surgery |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Co-sponsor | |
Name of secondary funder(s) |
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 | 大阪大学医学部付属病院(大阪府)、大阪府立成人病センター(大阪府)、近畿大学医学部付属病院(大阪府) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005364 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |