Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients

• Status: Completed
• Trial end date: 2019-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Hydroxocobalamin; Neuroprotective Agents; Pyridoxal; Pyridoxine; Vincristine; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

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)