Neuroprotective Effect of Vitamin B12 and Vitamin B6 Against Vincristine Induced Peripheral Neuropathy

NCT02923388 | Completed Phase 4

• 1 other identifier: No. BSMMU/2016/8305
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be conducted to evaluate the effect of vitamin B12 and vitamin B6 in delaying the onset and reducing the incidence and severity of Vincristine Induced Peripheral Neuropathy (VIPN) in Acute Lymphoblastic Leukemia (ALL) patient.

Conditions

Vincristine Induced Peripheral Neuropathy (VIPN)

Outcome Measures

Primary Outcomes (3)

• Time of onset of Vincristine Induced Peripheral Neuropathy

  0 weeks (baseline), change in neuropathy status on the outset 2nd week, 3rd week, 4th week and 5th week of vincristine chemotherapy

• Severity of Vincristine Induced Peripheral Neuropathy

  On the outset of 1st week change in the severity of neuropathy on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy

• Incidence of Vincristine Induced Peripheral Neuropathy

  Cumulative incidence at 5th week of vincristine chemotherapy

Study Arms (2)

Experimental

ACTIVE COMPARATOR

Intervention: Injection Mecobalamin (500mcg) three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks. Intervention: Tablet Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks.

Drug: Injection Mecobalamin,; Drug: Tablet Pyridoxine hydrochloride

Placebo

PLACEBO COMPARATOR

Intervention: Injection normal saline (1 ml) three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks. Intervention: Oral placebo pill 2 tablets thrice daily for 5 weeks.

Drug: Intravenous normal saline 1 ml; Drug: Placebo pill

Interventions

Injection Mecobalamin, DRUG

Injection Mecobalamin (500mcg) three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks.

Also known as: Vitamin B12

Experimental

Tablet Pyridoxine hydrochloride DRUG

Tab. Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks

Also known as: Vitamin B6

Experimental

Intravenous normal saline 1 ml DRUG

Normal saline 1 ml three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks

Also known as: Normal saline

Placebo

Placebo pill DRUG

Placebo pill orally thrice daily for 5 weeks

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients, 18 years of age or older with newly diagnosed ALL going to start induction chemotherapy with Vincristine
• Patients with good performance status (ECOG 0- 3)
• Patients with no preexisting peripheral neuropathy
• Patients with grade 0 neuropathy on admission
• Patients with normal renal function (Serum creatinine \<1.5 mg/dl)
• Patients agree to participate in the study signing an informed written consent

You may not qualify if:

• Pregnant women and nursing mothers
• Patients with clinical neuropathy due to diabetes mellitus or other causes
• Patients with head neck tumors
• Patients taking anticonvulsants, antidepressants, opioids, vitamin E and other neuropathic pain medication agents

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (2)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

Dhaka Medical College Hospital

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

Vitamin B 12; Vitamin B 6; Saline Solution

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Picolines; Pyridines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Pharmacology, BSMMU

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: October 4, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)