Oral Mucositis
Conditions
Keywords
Caphosol, Oral Mucositis, Eusa Pharma, Moffitt Cancer Center
Brief summary
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.
Interventions
DEVICECaphosol
Oral Mouth Rinse
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol. | 15 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake) | 15 weeks |
Countries
United States
Contacts
Primary ContactMichael Manyak, MD
Backup ContactColleen Gramkowski, MST
Outcome results
None listed