UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011956 |
|---|---|
| Receipt number | R000013965 |
| Scientific Title | Prophylactic effect of Elental on stomatitis in chemotherapy with or without radiation for esophageal cancer |
| Date of disclosure of the study information | 2013/10/03 |
| Last modified on | 2014/11/23 15:08:53 |
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Basic information
Public title
Prophylactic effect of Elental on stomatitis in chemotherapy with or without radiation for esophageal cancer
Acronym
Prophylactic effect of Elental
Scientific Title
Prophylactic effect of Elental on stomatitis in chemotherapy with or without radiation for esophageal cancer
Scientific Title:Acronym
Prophylactic effect of Elental
Region
| Japan |
Condition
Condition
Esophagealcancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of supportive care by the elemental diet (Elental) against gastrointestinal toxicity from chemotherapy with or without radiation in patients with esophageal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency or severity of oral erosion
Key secondary outcomes
1.Frequency of diarrhea, nausea or vomitting
2.Frequency of comlpetion of chemoradiotherapy of chemotherapy
3.decrease of Nutrition marker
4.loss of body weight
5.intake of Elental
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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 |
Interventions/Control_1
Elental (1 pack per day) during radiation or chmeradiation
Interventions/Control_2
No administration of Elental
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 esophageal cancer
2.lesions located in the thoracic esophagus
3. M3 or deeper
4. No prior chemo(-radio)therapy
5. over 20 and under 80 years of age
6. PS 0-2
7. Adequate oragn functions
8. Written informed consent
Key exclusion criteria
1. patients withe the past history of allergy to iodine
2. patients without cessation of anticoagulant therapy
3. Presence of other cancer
4. Pregnant or nursing women and those with the possibility of pregnancy
5. Mental or neurologic disease that might affect participation
6. Receiving steroid therapy
7. Positive HBs Antigen
8. Active infection
9. Presence of recent MI or history of unstable AP
10. Presence of uncorolled diabetes
11. Presence of uncontrolled hypertention
12. Presence of IP, pulmonary fibrosis, or severe CPE
13. patients with the past history of hypersensitivity to Elental
14. Abnormality in amino acid metabolism
15. patients considered inadequate for inclusion in this trial by the physician
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Kaise |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon Minato-ku Tokyo
TEL
03-3588-1111
kaise@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Iizuka |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon Minato-ku Tokyo
TEL
03-3588-1111
Homepage URL
t-iizuka@toranomon.gr.jp
Sponsor or person
Institute
Department of Gastroenterology, Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 03 | Day |
Last modified on
| 2014 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013965
