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To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area

Phase 2
Recruiting
Conditions
Colorectal Cancer
Registration Number
JPRN-UMIN000010438
Lead Sponsor
Osaka City University Graduate School of Medicine Department of Surgical Oncology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

Exclusion Criteria

1)transfusion, G-CSF etc. within 7days 2)severe allergic reaction 3)peripheral neuropthy 4)Simultaneous or metachronous double cancers 5)Active infectious disease 6)Severe mental disease 7)Grade2+, diarrhea 8)systemic administration of corticosteroids 9)Pregnant or lactating women or women of childbearing potential 10)Severe comorbidity (interstitial peumonitis, lung fibrosis, paralytic ileus, mechanical ileus, uncontrollable diabetes, liver cirosis, chronic hepatitis, career with hepatitis B/C, renal failure, heart failure, uncontrollable hypertension, unstable angina etc) 11)AMI within 6 months 12)History of transplantation 13)Preoperative therapy for CRC 14)History of colostomy 15)Unhealing of post-operative complication 16)Gashajinkigan, or drug for neuropathy 17)Any other cases who are regarded as inadequate for study enrollment by the investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time to neuropathy(grade<2:CTCAEv4.0)
Secondary Outcome Measures
NameTimeMethod
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