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

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00901732
• Other study ID #: 603EUSA03
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 13, 2009
• Last updated: May 13, 2009
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2009
• Source: Jazz Pharmaceuticals
• Contact: Michael Manyak, MD
• Phone: 609-750-8200
• Email: michael.manyak[@]eusapharma.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Caphosol
Oral Mouth Rinse

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida College of Medicine	Gainesville	Florida
United States	MD Anderson Cancer Center	Houston	Texas
United States	Beth Israel Medical Center	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)		15 weeks	No