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Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia

Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia - Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008917
Enrollment
75
Registered
2012-09-15
Start date
2011-08-01
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

gastric cancer

Interventions

administration of two packs (480 ml) daily of Prosure for 6 month

Sponsors

Nutrition on Cancer Chemotherapy Conference
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - advanced, recurrent, or R1 or R2 post operative gastric cancer - first-line chemotherapy - written informed consent obtained from patients or or legal representatives - male or female of 20 - 80 years-old at informed consent - ability of oral intake and maintained gastrointestinal function - estimated prognosis longer than three months (PS0 - 2) - albumin<3.5g/dl and CRP>=0.5mg/dl - assured tolerance to Prosure at pre-interventional test

Exclusion criteria

Exclusion criteria: - intestinal obstruction (inability of oral intake) - obvious infection focus - severe heart, liver, or kidney disease - uncontrollable diabetes mellitus - hyperlipidemia resistant to treatment - past history of chronic inflammatory disease - past history of allergy to contents of Prosure (milk, soybean etc) - probable pregnancy and/or lactation

Design outcomes

Primary

MeasureTime frame
time to treatment failure (TTF) of a first-line chemotherapy

Secondary

MeasureTime frame
overall survival progression free survival nutritional assessment (serum CRP,serum albumin,detachment rate form group D,TLC,body weight,BMI) QOL(Quality of life) comparison with a control group

Countries

Japan

Contacts

Public ContactHiroshi Imamura

Sakai City Hospital Surgery

0722-21-1700

Outcome results

None listed

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