Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT

What Was Tested

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

Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC).

It had two arms (groups): FORRAD group (experimental) and Quadruple mixture group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Nasopharyngeal carcinoma (NPC) is one of the most common malignances in South China.

Radiation therapy remains the principal treatment for NPC.

Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays, the incidence of radiation-induced oral mucositis is still high.

Common clinical management strategies include bland rinses, topical anesthetics and analgesics, mucosal coating agents, and systemic analgesics.

Who Took Part

Enrollment: 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, with intensity-modulated radiation therapy (IMRT). Life expectancy of \>= 3 months.

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: other conditions that the investigators consider as inappropriate for enrolling into this study.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

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

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 2016-04 with completion listed for 2017-06.

It ran at 1 site in China.

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). OMAS (time frame: Day 56 after completion or termination of radiotherapy). OMDQ MTS question 2 (Q2) score (time frame: Day 56 after completion or termination of radiotherapy).

It also tracked 5 secondary outcomes, for example Interruption time during the schedule of radiotherapy, Time for healing of radiation-induced oral mucositis, The cumulative time using opioid and The change of body weight from baseline.

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.