Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Status:	Completed
Conditions:	Cancer, Dental
Therapuetic Areas:	Dental / Maxillofacial Surgery, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/2/2016
Start Date:	May 2009
End Date:	November 2010
Contact:	Michael Manyak, MD
Email:	michael.manyak@eusapharma.com
Phone:	609-750-8200

Patients who have been diagnosed with a head and/or neck cancer commonly develop oral
mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to
evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral
intake, swallowing function and pain.

Inclusion Criteria:

- Diagnosed Head and Neck Cancer patients with planned Radiation therapy

- Have at least one of 10 pre-defined anatomic mucosal subsites on view

- Age >/= 18 years

- Life expectancy >/= 6 months

- Planned RT to the head/neck

- Must be able to perform oral rinse

Exclusion Criteria:

- Active infections of oral cavity

- physiologic condition that precludes the use of an oral rinse

- Hypersensitivity to Caphosol ingredients

- Presence of mucosal ulceration at baseline

- Poorly controlled hypertension, DM or other serious medical/psychiatric illness

We found this trial at

sites

Duke Univ Med Ctr

2301 Erwin Rd
Durham, North Carolina 27710

919-684-8111