Clinical trial · Interventional
Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients
Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients
NCT03593304CI-TRIAL-00045842completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will be conducted to evaluate the effect of vitamin B6 and vitamin B12 in reducing the incidence and severity and delaying the onset of Vincristine Induced neurotoxicity in Acute Lymphobalstic Leukemia (ALL) patient.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukaemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Vincristine Induced Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection Mecobalamin | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
| Oral Placebo | Drug | — | UNRESOLVED |
| Tablet Pyridoxine hydrochlorid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental:Mecobalamin and Pyridoxine hydrochloride
- description
- Injection Mecobalamin (500mcg) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.Tablet Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks.
- interventionNames
- Drug: Injection Mecobalamin
- Drug: Tablet Pyridoxine hydrochlorid
- type
- PLACEBO_COMPARATOR
- label
- Placebo: normal saline and Oral placebo
- description
- Injection normal saline (1ml) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.Oral placebo pill 2 tablets thrice daily for 5 weeks.
- interventionNames
- Drug: Normal saline
- Drug: Oral Placebo
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * All patients, 18 years of age or older with newly diagnosed ALL going to start induction chemotherapy with Vincristine * Patients ECOG Performance Status 0 to 3 * Patients with no preexisting autonomic neuropathy * Patients with normal renal function (Serum creatinine \<1.5 mg/dl) * No history of diabetes mellitus * Patients agree to participate in the study signing an informed written consent Exclusion Criteria: * Pregnant women and nursing mothers * Patients with clinical neuropathy due to diabetes mellitus and other causes like multiple sclerosis, spinal cord injury, post stroke * Patients with head neck tumors * Patients taking anticonvulsants, antidepressants, opioids, vitamin E and other neuropathic pain medication agents like topical anesthetic agents, non steroidal anti-inflammatory drugs (NSAIDs)
References
Publications (0)
Data not yet available
No reference posted for this study.