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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Oral Mucositis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

15 weeks

Safety Issue:

No

Principal Investigator

Andy M Trotti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Moffitt Cancer Center, Tampa Florida

Authority:

United States: Institutional Review Board

Study ID:

603EUSA03

NCT ID:

NCT00901732

Start Date:

May 2009

Completion Date:

November 2010

Related Keywords:

  • Oral Mucositis
  • Caphosol
  • Oral Mucositis
  • Eusa Pharma
  • Moffitt Cancer Center
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Beth Israel Medical CenterNew York, New York  10003
Temple University HospitalPhiladelphia, Pennsylvania  19140
Duke University Medical CenterDurham, North Carolina  27710
H. Lee Moffitt Cancer CenterTampa, Florida  33612
University of Florida College of MedicineGainesville, Florida  32610