Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000012936
- Lead Sponsor
- PerSeUS: Perpetual Study estimated-by United Sections in Gifu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
Not provided
1)Serious drug allergy 2)Neuropathy or sensory dysfunction 3)History of oxaliplatin treatment 4)Preventive administration for oxaliplatin-related neuropathy 5)Pain in the arm or foot 6) Current analgesic treatment 7)Active double cancer within the past 5 years 8)A systemic inflammatory condition or serious infection 9)Pregnant or lactating women 10)Serious psychological disease 11)Steroid treatment 12)Blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days 13)Pleural effusion, ascites, or pericardial effusion 14)Clinically significant heart disease 15)Clinically significant pulmonary disease 16)Gastrointestinal bleeding that requires medication or transfusion 17)Watery diarrhea 18)Ileus or bowel obstruction 19)Uncontrolled diabetes mellitus with or without diabetic neuropathy 20) Investigator's judgement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurotoxicity frequency of cumulative dose 500mg/m2 of oxaliplatin (Grade2 and more)
- Secondary Outcome Measures
Name Time Method 1)Cumurative dose to occurrence of neurotoxicity 2)Time to occurrence of neurotoxicity 3)The number of FOLFOX treatment courses 4)Relative dose intensity of oxaliplatin 5)FACT/GOG-Ntx and verval rating scale 6)Adverse events 7)Response rate 8)Progression free survival 9)Time to treatment failure