臨床研究等提出・公開システム

A prospective study to verify the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection of pancreatic cancer (Elental adjuvant S-1 trial)

Trial of the effectiveness of nutritional intervention for patients who are administered TS-1 after surgical resection of pancreatic cancer

(Elental adjuvant S-1 trial)

35

There are 35 registered people. There are 20 men and 15 women. 13 incompatible cases, 18 dropouts. There are 4 compatible cases.

35 registered cases 13 incompatible cases 18 dropouts cases 4 compatible cases

No illness affected by this clinical study

The number of compatible cases was extremely small and could not be analyzed.

The number of compatible cases was extremely small and could not be analyzed.

Mar. 16, 2021

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1051180068

Toyama Hirochika

Kobe University Hospital

7-5-2 Kusunokicyou Cyuou-ku Kobe-shi Hyogo, Japan

toyama@med.kobe-u.ac.jp

Asakura Yu

Kobe University Hospital

7-5-2 Kusunokicyou Cyuou-ku Kobe-shi Hyogo, Japan

+81-78-382-6302

yuuyuu383@yahoo.co.jp

Complete

Mar. 01, 2018

Interventional

single arm study

open(masking not used)

active control

single assignment

treatment purpose

Eligebility Criteria during hospital state
1)patients 20 years old or more
2)proven pancreatic cancer histlogecally
3)confirmed by R0 or R1 surgery
4)PS (ECOG) between 0 and 2
5)wityout any prior chemotherapy and/or radiation therapy
6)with good oral intake
7)written informed consent to participate in this study
8)without any severe diseases and with a good condition of important organs for administration of TS-1
a)WBC >= 2,500/mm3
b)neutrophil >= 1,200/mm3
c)platelet >=75,000/mm3
d)hemoglobin >= 8.0g/L
e)total bilirubin <= 1.5mg/dL
f)AST/ALT <= 100 IU/L
g)Creatinin clearance >= 40ml/min
CC by Cockcroft-Gault method is avilable

Exclusion Criteria during hospital stay
1)with active double cancer (*)
*Simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.
Carcinoma in situ or cancers localized in membranous layer are not included to double cancer.
Cancers removed by EMR/ESD are included.
2)with a history of allergy against TS-1 and/or Elental
3)with active infection diseases
4)with uncontrollable hypertension
5)with uncontrollable DM
6)with severe heart diseases clinically
7)with severe lung diseases (interstitial pneumonitis,pulmonary fibrosis, or pulmonary emphysema)
8)with psychologic diseases and/or psychological symptpms
9)women pregnant and/or nursing or women who like to be pregnant
10)patient registered to the other study whose endpoints are same to This study.
11)patients whom doctor decide not to register to this study

Both

pancreatic cancer

we perform nutritional support intervention by ELENTAL

Treatment Scedule
A total of 300kcal/day of Elental is administered for 42 days as one course.
Two courses administration is required with Elental, another two course is permitted without Elental.

One course(with Elental) :
TS-1 continuous administration for 28 days,after 14 days rest.
Elental continuous administration for 42 days.

One course(without Elental) :
TS-1 continuous administration for 28 days,after 14 days rest.

pancreatic cancer

the completion rate of S-1 adjuvant chemotherapy

1)Nutrition Indicator:Body weight,BMI,s-Albumin,s-Protein,s-Cholesterol
2)RP of TS-1 on 4 courses
3)the rate and grade of complication with nutritional intervantion
4)RP of Elental
5)muscular volume

+81-78-382-6669

Feb. 05, 2019

None