Hand and Foot Bath for Taxane-Induced Peripheral Neurotoxicity

What Was Tested

The trial (phase 4) is built around Cyanocobalamin (Vitamin B12).

It had two arms (groups): TCM arm (experimental) and methylcobalamin arm (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 78 planned participants were the target.

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: Development of grade ≥1 peripheral neurotoxicity after receiving a taxane-containing regimen, with continuation of this regimen for at least two additional cycles;. Age ≥18 years, male or female;. ECOG performance status score 0-1;. Adequate major organ function (cardiac, hepatic, renal, and bone marrow) within 7 days before treatment, meeting the following requirements:. Hematology (without blood transfusion within the previous 14 days):.

The full record lists 15 inclusion and 8 exclusion criteria; among the exclusions: pre-existing neurological disorders, including peripheral or central neuropathy;; known allergy to components of the investigational tcm formula;; neuropathy caused by electrolyte imbalance, diabetes, or other metabolic diseases;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

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

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2026-02-01 with completion listed for 2027-02-01.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by CTCAE v5.0. Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 Assessed by the MD Anderson Symptom Inventory-Traditional Chinese Medicine Module (MDASI-TCM). Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by Total Neuropathy Score-Clinical Version (TNSc).

It also tracked 3 secondary outcomes, for example Time to Peripheral Neurotoxicity Progression as Assessed by CTCAE v5.0, Change from Baseline in Quality of Life Scores (EORTC QLQ-C30 and QLQ-BR23) and Incidence of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 78 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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