Recruiting
Phase 1
Phase 2

Caphosol

Sponsor:

Jazz Pharmaceuticals

Code:

NCT00901732

Conditions

Oral Mucositis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Caphosol

Study Details

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.

Conditions

Oral Mucositis

Study ID

NCT00901732

Start date

May, 2009

Status verified date

May, 2009

Completion date

Nov, 2010

Anticipated

Primary completion date

Nov, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Interventions

Caphosol

Oral Mouth Rinse

Primary outcome measure

  • 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. [ Time Frame: 15 weeks ]

Central Contacts and Locations

Central contacts

Michael Manyak, MD

609-750-8200michael.manyak@eusapharma.com

Colleen Gramkowski, MST

609-750-8219colleen.gramkowski@eusapharma.com

Locations

University of Florida College of Medicine

Recruiting

Gainesville, Florida, United States, 32610

H. Lee Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Andy Trotti, MD

813-745-8424

Margaret Lotrimare

813-745-7223margaret.lomartire@moffitt.org

Beth Israel Medical Center

Recruiting

New York, New York, United States, 10003

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Jazz Pharmaceuticals

Last update posted

May 14, 2009

Last verified

May, 2009

Keywords

  • Caphosol
  • Oral Mucositis
  • Eusa Pharma
  • Moffitt Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jazz Pharmaceuticals on 2009-05-14.