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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051180068
Enrollment
75
Registered
2019-02-19
Start date
2018-04-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer pancreatic cancer

Interventions

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 El

Sponsors

Toyama Hirochika
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 = 40ml/min CC by Cockcroft-Gault method is avilable

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
the completion rate of S-1 adjuvant chemotherapy

Secondary

MeasureTime frame
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

Contacts

Public ContactYu Asakura

Kobe University Hospital

yuuyuu383@yahoo.co.jp+81-78-382-6302

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026