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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901732
Recruitment Status : Unknown
Verified May 2009 by Jazz Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : May 14, 2009
Last Update Posted : May 14, 2009
Information provided by:
Jazz Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Device: Caphosol Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Study Start Date : May 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

Intervention Details:
    Device: Caphosol
    Oral Mouth Rinse
    Other Name: supersaturated solution of calcium and phosphate ions.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake) [ Time Frame: 15 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901732

Contact: Michael Manyak, MD 609-750-8200
Contact: Colleen Gramkowski, MST 609-750-8219

United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32610
Contact: Robert Amdur, MD         
Contact: Bridgett Fitzgerald         
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Andy Trotti, MD    813-745-8424      
Contact: Margaret Lotrimare    813-745-7223   
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Kenneth Hu, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: David Brizel, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Curtis T Miyamoto, MD         
Contact: Jennifer Curry, RN         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Mark Chambers, MD         
Sponsors and Collaborators
Jazz Pharmaceuticals
Principal Investigator: Andy M Trotti, MD Moffitt Cancer Center, Tampa Florida
Study Director: David M Brizel, MD Duke University, Durham, North Carolina
Principal Investigator: David I Rosenthal, MD MD Anderson Cancer Center, Houston, Texas
Study Director: Mark Chambers, MD MD Anderson Cancer Center, Houston, Texas
Study Director: Curtis T Miyamoto, MD Temple University Hospital, Philadelphia, PA
Study Director: Kenneth Hu, MD Beth Israel Medical Center, New York, New York
Study Director: Robert Amdur, MD University of Florida, Gainesville, Florida

Responsible Party: Michael Manyak, MD / Medical Monitor, EUSA Pharma (USA), INc Identifier: NCT00901732     History of Changes
Other Study ID Numbers: 603EUSA03
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

Keywords provided by Jazz Pharmaceuticals:
Oral Mucositis
Eusa Pharma
Moffitt Cancer Center

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases