View Clinical Trial (Medical Research Study)
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
| City: |
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Tampa |
| State: |
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Florida |
| Zip Code: |
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33612 |
| Conditions: |
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Oral Mucositis |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00901732 |
| Primary Contact: |
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Principal Investigator
Andy M Trotti, MD
Moffitt Cancer Center, Tampa Florida
Michael Manyak, MD
Phone: 609-750-8200
Email: michael.manyak@eusapharma.com
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| Backup Contact: |
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Email: colleen.gramkowski@eusapharma.com
Colleen Gramkowski, MST
Phone: 609-750-8219
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| Location Contact: |
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Tampa, Florida 33612
United States
Andy Trotti, MD
Phone: 813-745-8424
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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