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

JRCT ID: jRCT1051180068

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 23/04/2018
• Target sample size: 75
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: the completion rate of S-1 adjuvant chemotherapy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Toyama Hirochika
• Secondary ID(s): 000029895