Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer

What Was Tested

The trial (phase 2) is built around Bestim.

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer.

This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis.

It had three arms (groups): 1 (placebo comparator), 2 (active comparator) and 3 (active comparator).

Placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 59 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: Subject must have a body weight less than 150 kg at screening. Plan to receive a continuous course of conventional external beam irradiation. Plan to receive a standard cisplatin chemotherapy regimen.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: pregnant or breastfeeding; have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor; prior radiation to the head and neck.

How the Study Was Run

The set-up was randomized, single-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Bestim and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Bestim, so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2008-09.

It ran at 19 sites in United States (19).

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy (time frame: 7 Weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bestim in 59 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Bestim compound page, all human trials.