A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients

What Was Tested

This registered phase 3 trial tested Cyanocobalamin (Vitamin B12).

Many types of chemotherapy may cause nerve damage as a side effect.

This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain).

It had two arms (groups): Multivitamin (MV) (active comparator) and Multivitamin + Vitamin B12 + Vitamin B6 (experimental).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

There is clinical and preclinical data that vitamin B6 and B12 may alleviate neuropathy in experimentally induced neuropathy in animal models, or clinical neuropathy such as diabetic neuropathy.

Patients will be stratified by type of chemotherapy agent (3 groups), presence or absence of neuropathy at baseline, and randomized to receive placebo or vitamin B6/B12 supplementation.

Who Took Part

319 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Taxanes, vinca alkaloid analogs, heavy metals. Each patient will be allocated to the following 3 groups:. Group 2 (Taxane): Patients treated with paclitaxel, docetaxel or abraxane. Group 3 (Vinca alkaloids): Patients treated with vincristine and vinorelbine. Patients must have a life expectancy of at least 24 weeks.

The full record lists 10 inclusion and 5 exclusion criteria; among the exclusions: patients with symptomatic brain metastases are excluded from this study; pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception; patients may receive no other concurrent complementary medicines during this study.

How the Study Was Run

It was run as a randomized, factorial and open-label study.

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.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2006-07 with completion listed for 2013-06.

It ran at 5 sites in United States (5).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Neurotoxicity Assessment at Baseline (time frame: At study start; prior to treatment (week 0)). Neurotoxicity Assessment at Cycle 2 (time frame: 2 weeks). Neurotoxicity Assessment at Cycle 4 (time frame: 4 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 319 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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