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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011956
Receipt No. 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

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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
Email 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
Email t-iizuka@toranomon.gr.jp

Sponsor
Institute Department of Gastroenterology, Toranomon Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013965

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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