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

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 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


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

Value
https://center6.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