GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy f… (NCT00293462) | Clinical Trial Compass
CompletedPhase 3
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
United States91 participantsStarted 2005-06-07
Plain-language summary
GM-CSF may protect normal cells from the side effects, such as mucositis, of radiation therapy and may help damaged tissue heal faster after radiation therapy. This randomized clinical trial is studying how well GM-CSF works in preventing and treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Histopathologically confirmed diagnosis of head and neck cancer
* Scheduled to undergo continuous course of conventional or hyperfractionated radiotherapy or intensity-modulated radiotherapy (IMRT) with or without concurrent chemotherapy
* Planning to receive a total radiation dose ≥ 5,500 centigray (cGy), administered in a single daily fraction of 180-220 cGy (5 days a week) or twice daily fractions of 110-150 cGy
* Normal baseline oral examinations (no pre-existing lesion)
* Karnofsky performance status 60-100%
* Mentally capable of participating in research protocol
* Expected survival \> 4.5 months
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2.0 mg/dL
* Aspartate aminotransferase (AST) \< 5 times upper limit of normal
* HIV negative
Exclusion Criteria
* No unresolved adverse event from previous therapy
* No prior radiotherapy to the head and neck
* No prior or concurrent brachytherapy
* No prior participation in this study
* No T1 or T2 glottic tumors
* No other serious concurrent medical illness
* No history of insulin-dependent diabetes mellitus
* No prior hypersensitivity reaction to yeast material
* No recent history of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis, or xerostomia
* No current New York Heart Association class II-IV congestive heart failure
* Not pregnant or nursing
* No chemotherapy, radiotherapy, or other in…
What they're measuring
1
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
Timeframe: From baseline to onset of mucositis, approximately 16 days
2
Comparison of the Mean Number of Days for Mucositis to Heal Across by Group
Timeframe: From onset of mucositis to healing of mucositis, approximately 80 days