Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000009464
- Lead Sponsor
- Toyama Prefectural Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1)Patients who had received blood transfusion, blood products , or hematopoietic growth factors such as granulocyte-colony stimulating factor(G-CSF) within 7 days prior to registration 2)with brain metastasis 3)with much cavity fluid to be removed 4)with active double cancer 5)allergy against medicines 6)uncontrolled Hypertension 7)Prior or current thrapy for neuropathy or sensory dysfunction. 8)uncontrolled DM 9)active infection desease 10)watery diarrhea 11)disorderon EKG 12)severe respiratory disease(interstital pneumonitis,plumonary fibrosis,Severe pulmonary emphysema) 13)psychiatric disorder 14)fresh bleeding on the digestive tract 15)pregnant and/or nursing women 16)Doctor's stop not to be registered
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurotoxicity frequency of accumulation dose 500mg/m2 of L-OHP (Grade2 or more)
- Secondary Outcome Measures
Name Time Method 1)Median dose of L-OHP 2)nerve disorder at the end of oxaliplatin-based regimen (each course Grade) 3)the psychometric properities of the FACT/GOG-Ntx 4)PFS and TTF 5)response rate