Unique ID issued by UMIN | UMIN000007609 |
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Receipt number | R000008985 |
Scientific Title | A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer. |
Date of disclosure of the study information | 2012/03/30 |
Last modified on | 2021/04/13 05:07:47 |
A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.
A clinical trial of the effect of the elemental diet on adverse events of DCF therapy in patients with esophageal cancer.
A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.
A clinical trial of the effect of the elemental diet on adverse events of DCF therapy in patients with esophageal cancer.
Japan |
esophageal cancer
Gastroenterology |
Malignancy
NO
To evaluate the efficacy of supportive care by the elemental diet (Elental) against gastrointestinal toxicity from DCF therapy in patients with esophageal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase III
The incidence of gastrointestinal toxicity (grade 2 or higher) during three courses of DCF therapy
The following are assesed during three courses of DCF therapy,
1) Incidence of adverse events
2) Nutritional condition s(body weght, muscle mass, blood test, urine analysis, N-balance)
3) Quality of Life
4) Response rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Patients of this trial group will take two packs of the elemental diet (Elental) a day as long as possible after initiation of DCF therapy.
When taking two packs is difficult, the dosage of the elemental diets (Elental) will be reduced suitable for the patient condition..
Patients of this control group will take regular diet only.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
The following patients
(1) patients with histological squamous cell carcinoma
(2) patients in stage II/III/IV (UICC ver.7)
(3) patients receiving DCF therapy (DTX750mg/m2,day1), CDDP(75mg/m2,day1), 5-FU(750mg/m2,day1-5)
(4) 20<=age of patient <=80years-old
(5) patients having PS=0,1,2
(6) patients being able to take the elemental diet (Elental)
(7) patients who agreed with written informed consent
The following patients
(1) patients considered inadequate for inclusion in this trial by the physician
(2) patients with the past history of hypersensitivity to Elental
80
1st name | |
Middle name | |
Last name | Wasaburo Koizumi |
Kitasato University School of Medicine
Gastroenterology
1-15-1 Kitasato, Sagamihara, Kanagawa
1st name | |
Middle name | |
Last name | Chikatoshi Katada |
Kitasato University School of Medicine
Gastroenterology
1-15-1 Kitasato, Sagamihara, Kanagawa
042-778-8111
ckatada@med.kitasato-u.ac.jp
Department of Gastroenterology
Kitasato University School of Medicine
None
Self funding
None
NO
2012 | Year | 03 | Month | 30 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 21 | Day |
2011 | Year | 12 | Month | 21 | Day |
2012 | Year | 03 | Month | 01 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 10 | Day |
2012 | Year | 03 | Month | 29 | Day |
2021 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008985
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