Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis

What Was Tested

The trial (phase 2) is built around Cyanocobalamin (Vitamin B12).

It had two arms (groups): Arm A (experimental) and Arm B (active comparator).

The registry classes the interventions as drug.

More on the Plan

Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma. 2.

Age between 18 and 65 years. 4.

Patient who has given his/her written consent before any specific procedure of the protocol.

Pregnant or breast-feeding females. 3.

Who Took Part

The registry lists 160 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: Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma. Age between 18 and 65 years. Patient who has given his/her written consent before any specific procedure of the protocol.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: severe uncontrolled infection; pregnant or breast-feeding females; allergy to this medicine.

How the Study Was Run

It was run as a randomized, parallel-group 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.

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 2013-03 with completion listed for 2014-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The incidence of grade II and less oral mucositis at the end of treatment (time frame: 7 weeks).

It also tracked 4 secondary outcomes, for example Pain, Cumulative incidence and time of grade III and more oral mucositis, Dysphagia and Tumor response to chemoradiotherapy.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 160 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.