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

Jazz Pharmaceuticals

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Oral Mucositis

Treatments: Device: Caphosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00901732

603EUSA03

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)