Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis

What Was Tested

In this phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

Radiation therapy is one of the treatments for Nasopharyngeal carcinoma .

The most common side effects of post-radiation may be radiation-induced oral mucositis .

It had two arms (groups): Recombinant bovine basic fibroblast growth factor (experimental) and Quadruple mixture (active comparator).

Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition.

The registry classes the interventions as combination product and drug.

Who Took Part

The registry lists 90 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Pathologically confirmed and previously untreated nasopharyngeal carcinoma. Age ≥ 18 years and ≤ 65 years. Karnofsky performance status (KPS) score ≥ 70. Planned to receive radiotherapy alone or concurrent chemoradiotherapy. Life expectancy of \>= 3 months.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: younger than 18 years old or older than 70 years old; pregnancy or lactation; severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

It started in 2018-12-21 with completion listed for 2019-12-20.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of grade ≥ 3 mucositis (time frame: Day 56 after completion or termination of radiotherapy). EORTC QLQ-C30 (time frame: Day 56 after completion or termination of radiotherapy). WHO score (time frame: Day 56 after completion or termination of radiotherapy).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 90 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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