Supportive Care / Symptom Management (Prevention of Cancer Morbidity)
Projects and Investigators
Management of Mucositis with GM-CSF
| Principal Investigator: | Dodd, Marylin J. |
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| Institution: | University of California San Francisco |
| State: | CA |
| Research Category: | Mucositis |
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| NCI Program Director: | O'Mara, Ann |
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| NCI Division: | Division of Cancer Prevention |
| Project ID: | R01, CA107080 |
| Project Funding Period: | 9/11/03 to 8/31/08 |
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Program Description:
The study consists of a double-blind randomized controlled trial (RCT) conducted in two phases to test the effectiveness of prevention and treatment mouthwashes for radiation therapy (RT)-induced mucositis. The primary purposes are to: 1) test the effectiveness of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) and Salt & Soda mouthwashes in preventing RT-induced oral mucositis in persons who are receiving RT for head and neck cancer (HNC); 2) test the effectiveness of these same two mouthwashes in treating RT-induced oral mucositis; 3) determine the impact of the prevention and treatment phases on direct and indirect indices of RT-induced oral mucositis morbidity. The research design will block for dose schedule and for the concurrent use of chemotherapy. All patients will carry out a systematic oral hygiene teaching program: PRO-SELF: MOUTH AWARE (PSMA). In the prevention phase 222 outpatients, initiating a course of RT for HNC will be randomized to either PSMA (performed B.I.D.) plus mouthwashes (Q.D.) of: A) GMCSF; or B) Salt & Soda. Patients who do not develop oral mucositis will come off study at the completion of RT. In the treatment phase patients who develop RT-induced oral mucositis anytime during the RT will perform PSMA Q.I.D. If they were already using GM-CSF during the prevention phase, they are to continue to use this mouthwash (Q.D.) If they were using Salt & Soda mouthwash during the prevention phase, they will be randomized to either continue to use the Salt & Soda mouthwash Q.D. or to begin a new course of GM-CSF mouthwash Q.D. Patients in the treatment phase will use the mouthwashes until the mucositis is healed. Morbidity will include: incidence, centigrays to onset of mucositis, severity, mucositis-related pain, infection, and problems with ingestion of food and fluid in the prevention phase. Time to healing of the mucositis will be added in the treatment phase. Indirect indices of mucositis will include: tolerance to RT, functional status, and quality of life.
