ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial

UnknownOBSERVATIONAL
Enrollment

180

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Oral MucositisNauseaVomitingDiarrhea
Interventions
DEVICE

ProThelial

August 2013, the FDA cleared the use of ProThelial, a polymerized high potency sucralfate paste, as a device for the management of oral mucositis.Standard potency non-polymerized sucralfate is not recommended by MASCC/ISOO for the treatment or prevention of mucositis, oral or alimentary. However high potency polymerized sucralfate has been associated with rapid amelioration and prevention of both oral and alimentary mucositis in a patient with advanced head neck cancer treated simultaneously with high dose chemo-radiation. High potency sucralfate is standard sucralfate polymerized into 'sucralfate sheets' that adhere and orderly layer upon the mucosa achieving and maintaining elevated concentrations of sucralfate long after the initial dose administration. Three hours following administration, high potency sucralfate maintains a 7 fold greater surface concentration of sucralfate on normal lining and a 23 fold greater concentration on inflamed, ulcerated mucosa.

Trial Locations (1)

02825

Translational Medicine Research Center, Foster

Sponsors
All Listed Sponsors
lead

Ashley Downs Bioscience

INDUSTRY

NCT02016807 - ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial | Biotech Hunter | Biotech Hunter