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Efficacy of Rikkunshito on the Development and Progression of Cachexia in Gemcitabine-treated Pancreatic Cancer Patients – Randomized Phase II Study

Phase 2
Conditions
Patients with unresectable pancreatic cancer who are going to be treated with gemcitabine
Registration Number
JPRN-UMIN000008066
Lead Sponsor
ational Cancer Center Research Insititute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with cerebral metastases 2)Patients with peritoneal or pleural dissemination 3)Patients with ascites or pleural effusion 4)Patients with double cancer 5)Patients with interstitial pneumonia, lung fibrosis and severe pulmonary emphysema 6)Patinets with seizure disorder requiring anticonvulsants 7)Patients with disturbed consciousness 8)Patinets with gastrointestinal obstruction 9)Patients participating in other clinical trials 10)Patients with uncontrollable hypertension 11)Patients with diabetes mellitus treated with insulin, or uncontrollable diabetes mellitus 12)Patients with taking corticosteroid, androgen, progesterone or any other orexigenic medicine 13)Pregnant woman, Nursing woman, or woman not to agree with contraception 14)Pateints with infection requiring systemic treatment 15)Patiens having body temperature of >=38degrees at the enrollment 16)Patients with psychiatric disorder or any psychiatric symptoms, or considered in ineligible to the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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