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

NCT03593304 | Completed Phase 2

• 1 other identifier: No. BSMMU/2018/2105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Vincristine Induced Neurotoxicity; Acute Lymphoblastic Leukaemia

Outcome Measures

Primary Outcomes (3)

• Incidence of Vincristine Induced neurotoxicity

  Cumulative incidence at 5th week of vincristine chemotherapy

• Severity of Vincristine Induced neurotoxicity

  Changes of severity will be assessed by COMPASS 31 on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy

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

• Time of onset of Vincristine Induced Neurotoxicity

  change in neurotoxicity status on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy

  1st week (baseline), change in neurotoxicity status on the outset 2nd week, 3rd week, 4th week and 5th week of vincristine chemotherapy

Study Arms (2)

Experimental:Mecobalamin and Pyridoxine hydrochloride

ACTIVE COMPARATOR

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.

Drug: Injection Mecobalamin; Drug: Tablet Pyridoxine hydrochlorid

Placebo: normal saline and Oral placebo

PLACEBO COMPARATOR

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.

Drug: Normal saline; Drug: Oral Placebo

Interventions

Injection Mecobalamin DRUG

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

Also known as: Vitamin B12

Experimental:Mecobalamin and Pyridoxine hydrochloride

Tablet Pyridoxine hydrochlorid DRUG

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

Also known as: Vitamin B6

Experimental:Mecobalamin and Pyridoxine hydrochloride

Normal saline DRUG

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

Also known as: Placebo for mcobalamin

Placebo: normal saline and Oral placebo

Oral Placebo DRUG

Placebo Oral Tablet (25 mg) 2 tablets thrice daily for 5 weeks.

Also known as: Placebo for pyridoxine hydrochloride

Placebo: normal saline and Oral placebo

Eligibility Criteria

• Age: 18 Years - 85 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 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (2)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Shahbag, 1000, Bangladesh

Location

Dhaka Medical College Hospital

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Vitamin B 12; Vitamin B 6; Saline Solution; Pyridoxine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Pharmacology, BSMMU

Model Details: Experimental group: Medicine- Injection Mecobalamin (500mcg), Tablet Pyridoxine hydrochloride (25 mg) Placebo group: Injection normal saline (1ml), oral placebo pill

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: July 20, 2018
• Study Start: March 29, 2018
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2019
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

BA (2)