Unique ID issued by UMIN | UMIN000026705 |
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Receipt number | R000030404 |
Scientific Title | Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study. |
Date of disclosure of the study information | 2017/05/01 |
Last modified on | 2019/10/01 22:38:14 |
Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.
DiCON study
Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.
DiCON study
Japan |
advanced esophageal and gastric cancer
Medicine in general | Gastroenterology |
Malignancy
NO
To evaluate appropriate amount of oral nutritional supplement(ONS) to keep body weight for patients with advanced esophageal and gastric cancer who needs systemic chemotherapy.
Safety
Exploratory
Not applicable
Changes in the ratio of prealbumin before and after administration of ONS
Compliance of ONS, Changes in the ratio of various nutritional index before and after administration of ONS
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
YES
Numbered container method
4
Treatment
Food |
only Diet Counseling
administration ONS once a day for 14 days
administration ONS twice a day for 14 days
administration ONS three times a day for 14 days
20 | years-old | <= |
Not applicable |
Male and Female
1)advanced gastric cancer or esophageal cancer
2)patients who plans 1st line chemotherapy or chemoradiotherapy
3)patients who can eat more than 50%
4)An age of over 20
5)PS ECOG performance status score 0-1
6)Major organs are in normal conditions in 14 days of administration
neutrophil count => 1,500/mm3
Hemoglobin => 8.0g/dL
Platelet count => 100,000/mm3
Serum bilirubin <= 1.5 mg/dL
AST<=100 IU/L
ALP<=100 IU/L
Serum creatinine <= 2.0 mg/dL
Written informed consent must be taken by patients
1)ileus or subileus symptom
2)Active infectious diseases(except local infection)
3)massive ascites
4)weight loss more than 10%
5)plans triplet chemotherapy for 1st line chemotherapy
6)allergy for ONS
7)Uncontrollable DM
8)Pregnant or lactation women, or women with the possibility of the pregnancy
9)need systemic steroid therapy
10)Severe mental disorders, neurological disease
11)Dementia
12)Patients who are judged inappropriate for the entry into this study by the investigator
40
1st name | Takashi |
Middle name | |
Last name | Ichimura |
Cancer Institute Hospital
Gastroenterological Chemotherapy Department
1358550
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
03-3520-0111
takashi.ichimura@jfcr.or.jp
1st name | Yukiko |
Middle name | |
Last name | Izawa |
Cancer Institute Hospital
Department of Nutrition
1358550
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
03-3520-0111
yukiko.izawa@jfcr.or.jp
Cancer Institute Hospital
Gastroenterological Chemotherapy Department
Cancer Institute Hospital
Gastroenterological Chemotherapy Department
Self funding
clinico corporation
Cancer Institute Hospital
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
03-3570-0210
med.shinsa@jfcr.or.jp
NO
2017 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 03 | Month | 09 | Day |
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 07 | Month | 25 | Day |
2019 | Year | 10 | Month | 01 | Day |
2019 | Year | 10 | Month | 01 | Day |
2019 | Year | 10 | Month | 31 | Day |
2019 | Year | 12 | Month | 30 | Day |
2017 | Year | 03 | Month | 26 | Day |
2019 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030404
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