Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO)
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000004286
- Lead Sponsor
- PO Epidemiological and Clinical Research Information Network (ECRIN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1)Serious drug allergy. 2)Neuropathy or sensory dysfunction. 3)Pain in the arm. 4)Current analgesic treatment. 5)Active double cancer within the past 5 years. 6)Serious psychological disease. 7)Steroid treatment. 8)blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days . 9)Pleural effusion, ascites, or pericardial effusion. 10)Clinically significant infection. 11)brain metastasis 12)Clinically significant heart disease (myocardial infarction within 12 months, etc.). 13)Clinically significant pulmonary disease 14)bleeding that requires medication or transfusion. 15)Watery diarrhea. 16)Ileus or bowel obstruction. 17)Central nervous system disorders. 18)Dementia or clinically significant mental/neurological disorders. 20)Investigator's judgement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of venous pain:Grade>=2
- Secondary Outcome Measures
Name Time Method 1)time to occurrence of venous pain 2)adverse events 3)response rate 4)time to treatment failure 5)overall survival