A trial evaluating the efficacy and safety of Laftidine for protection against vincristine-induced peripheral neuropathy.
- Conditions
- Malignant lymphoma
- Registration Number
- JPRN-UMIN000022072
- Lead Sponsor
- Department of Hematology and Oncology, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Patients with hypersensitivity reaction for lafutidine 2. Patients with active disease except for malignant lymphoma. 3. Patients with peripheral neuropathy. 4. Patients with oral drugs that affect the neurological disorder.(Methylcobalamin, Anticonvulsants(Pregabalin, Gabapentin , Carbamazepine) , Tricyclic antidepressants( Amitriptyline, Nortriptyline, Amoxapine) ,Serotonin and norepinephrine reuptake inhibitors(Duloxetine), Antiarrhythmic drugs(Mexiletine, Flecainide) , Goshajinkigan, Shakuyakukanzoutou, etc.) 5. The patients who are receiving H2 antagonist or proton pump inhibitors, and who cannot stop these drugs. 6. Patients who require administration of Intrathecal chemotherapy. 7. Patients with severe hypersensitivity reaction for any medications. 8. Patients with HIV infection 9. Pregnant women. 10. Breast feeding women. 11. Patients who considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 12. Patients who do not agree with his or her intention 13. Patients whom the doctor recognizes unsuitable subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint was the incidence of peripheral neuropathy grade 1 with neuropathic pain and grater than Grade2 as graded by the CTCAE v. 4.0 criteria.
- Secondary Outcome Measures
Name Time Method