Status:
COMPLETED
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Lead Sponsor:
Marilyn Dodd
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Mucositis Oral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 studyi...
Detailed Description
OBJECTIVES: Primary * Compare the incidence of radiotherapy (RT)-induced oral mucositis of any grade, using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria (RTOG ARMS...
Eligibility Criteria
Inclusion
- 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 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
Exclusion
Key Trial Info
Start Date :
June 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2009
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00293462
Start Date
June 7 2005
End Date
December 31 2009
Last Update
July 30 2021
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143