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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Eusapharma.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901732
First Posted: May 14, 2009
Last Update Posted: May 14, 2009
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.
Information provided by:
Eusapharma
  Purpose
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 Intervention Phase
Oral Mucositis Device: Caphosol Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Eusapharma:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Caphosol
    Oral Mouth Rinse
    Other Name: supersaturated solution of calcium and phosphate ions.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00901732


Contacts
Contact: Michael Manyak, MD 609-750-8200 michael.manyak@eusapharma.com
Contact: Colleen Gramkowski, MST 609-750-8219 colleen.gramkowski@eusapharma.com

Locations
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    margaret.lomartire@moffitt.org   
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
Investigators
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
  More Information

Responsible Party: Michael Manyak, MD / Medical Monitor, EUSA Pharma (USA), INc
ClinicalTrials.gov Identifier: NCT00901732     History of Changes
Other Study ID Numbers: 603EUSA03
First Submitted: May 13, 2009
First Posted: May 14, 2009
Last Update Posted: May 14, 2009
Last Verified: May 2009

Keywords provided by Eusapharma:
Caphosol
Oral Mucositis
Eusa Pharma
Moffitt Cancer Center

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