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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by EUSA Pharma (US), Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
EUSA Pharma (US), Inc.
ClinicalTrials.gov Identifier:
NCT00901732
First received: May 13, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by EUSA Pharma (US), Inc.:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 Names:
    • Caphosol
    • supersaturated solution of calcium and phosphate ions.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
EUSA Pharma (US), Inc.
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

No publications provided

Responsible Party: Michael Manyak, MD / Medical Monitor, EUSA Pharma (USA), INc
ClinicalTrials.gov Identifier: NCT00901732     History of Changes
Other Study ID Numbers: 603EUSA03
Study First Received: May 13, 2009
Last Updated: May 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by EUSA Pharma (US), Inc.:
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

ClinicalTrials.gov processed this record on September 16, 2014