Unique ID issued by UMIN | UMIN000006274 |
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Receipt number | R000006019 |
Scientific Title | The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancer |
Date of disclosure of the study information | 2011/10/01 |
Last modified on | 2017/05/16 19:16:32 |
The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancer
The effects of ONS during chemoradiotherapy in patients with pancreatic and/or esophageal cancer
The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancer
The effects of ONS during chemoradiotherapy in patients with pancreatic and/or esophageal cancer
Japan |
Patients with pancreatic and/or esophageal cancer, who are scheduled to receive chemoradiotherapy
Gastroenterology | Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the effects of ONS (Oral Nutritional Supplement) during chemoradiotherapy for patients with pancreatic and/or esophageal cancer
Efficacy
Exploratory
Pragmatic
To evaluate the effects of Oral Nutritional Supplement (before chemoradiotherapy, 3 weeks after the beginning of chemoradiotherapy and 1 week after chemoradiotherapy) using the Prognostic Nutrition Index (PNI)
Serum albumin level
Lymphocyte count
Arm circumference(AC)
Triceps subcutaneous fat(TSF)
Body weight and body composition
Amount of food intake
QOL(EORTC QLQ-C30)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
NO
Central registration
2
Treatment
Other |
For the interventional group, an amount of 500ml/day of oral nutritional supplement(Ensure)is administered for patients who receive chemoradiotherapy(CRT)This nutrition intervention is performed from the start of chemoradiotherapy to the completion of chemoradiotherapy.
For the control group, diet therapy alone and oral nutritional supplement(Ensure) is administered after onset of anorexia
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with pancreatic and/or esophageal cancer, who are scheduled to receive chemoradiotherapy
2.Histologically confirmed pancreatic and/or esophageal cancer
3.Patients of age =>20
4.Life expectancy more than 2 months
5.Performance Status: 0-2 (ECOG)
6.Written informed consent
1.Patients on TPN [total parenteral nutrition]
2.Patients with milk protein allergy
3.Patients with Dysphagia
4.Patients who are judged inappropriate for the entry into the study by the investigater
50
1st name | |
Middle name | |
Last name | Tatsuya Ioka |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
06-6972-1181
ioka-ta@mc.pref.osaka.jp
1st name | |
Middle name | |
Last name | Tatsuya Ioka |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
06-6972-1181
ioka-ta@mc.pref.osaka.jp
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
Osaka Prefecture
Self funding
Japan
NO
2011 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2010 | Year | 05 | Month | 01 | Day |
2010 | Year | 06 | Month | 01 | Day |
2017 | Year | 05 | Month | 31 | Day |
2011 | Year | 09 | Month | 02 | Day |
2017 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006019
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