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

What Was Tested

This registered phase 4 trial tested Cyanocobalamin (Vitamin B12).

It had two arms (groups): Experimental (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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

One of the crucial chemotherapeutic agents used to treat ALL is vincristine.

Better prognostic outcome becomes an arcadia.

Who Took Part

88 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 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 with good performance status (ECOG 0- 3). Patients with no preexisting peripheral neuropathy. Patients with grade 0 neuropathy on admission. 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 or other causes; patients with head neck tumors.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-10 with completion listed for 2018-06.

It ran at 2 sites in Bangladesh (2).

Its stated primary purpose is prevention.

What Was Measured

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

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 88 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.