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

What Was Tested

The trial (phase 2, phase 3) is built around Cyanocobalamin (Vitamin B12).

It had two arms (groups): Experimental:Mecobalamin and Pyridoxine hydrochloride (active comparator) and Placebo: normal saline and Oral placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Vincristine is one of the important chemotherapeutic agents used in combination with other medicines to treat Acute Lymphoblastic Leukemia (ALL).

Good prognostic outcome of ALL depends on uninterrupted and complete course of chemotherapy.

This study will be a multicenter, double blind, randomized controlled trial.

In this study newly diagnosed ALL patients will be enrolled in induction phase and patients will be randomly allocated into two arms by using online graph pad software.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. No history of diabetes mellitus. Patients agree to participate in the study signing an informed written consent.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2018-03-29 with completion listed for 2018-12-30.

It ran at 2 sites in Bangladesh (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of Vincristine Induced neurotoxicity (time frame: Cumulative incidence at 5th week of vincristine chemotherapy). Severity of Vincristine Induced neurotoxicity. Time of onset of Vincristine Induced Neurotoxicity.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.