GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

Completed · Phase 3

Conditions studied: Head and Neck Cancer, Mucositis Oral, Radiation Toxicity, Tongue Cancer

In brief

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.

Key facts

Study ID

NCT00293462

Run by

Marilyn Dodd

People needed

91

Starts

2005-06-07

Expected to finish

2009-12-31

Last updated by the study team

2021-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 investigational drugs within the past 4 weeks
• No major surgery within the past 2 weeks
• No systemic sargramostim (GM-CSF) within the past 7 days
• No systemic filgrastim (G-CSF) within the past 24 hours
• No systemic long-acting pegfilgrastim within the past 14 days
• No antibiotics, antifungals, or antivirals for oral conditions at baseline
• No other concurrent chemotherapy agent
• No concurrent enrollment on other head and neck studies
• No other concurrent investigational drugs
• No concurrent administration of any of the following:
• "Magic or miracle mouthwash" containing a palliative mixture of topical anesthetics/analgesics, coating agents, and other medications without an approved indication for topical oral use except liquid antacid formulations (e.g., Maalox® or Mylanta® or their generic equivalents)
• Other concurrent over-the-counter or prescription mouthwashes beyond the systematic oral care protocol provided by the study or any other drugs or agents to aid in oral hygiene (e.g., chlorhexidine, gluconate, pilocarpine, amifostine, sucralfate tablets or slurry, or benzydamine)
• Use of corticosteroids for chronic conditions OR within the past 7 days

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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