GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Head and Neck Cancer, Mucositis Oral, Radiation Toxicity
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Recurrent squamous, basal cell carcinoma of the pharynx,larynx,lip, Oropharynx, paranasal sinus and nasal cavity, Stage I-IV lymphoepithelioma of the nasopharynx, Stage I-IV lymphoepithelioma of the oropharynx, Recurrent esthesioneuroblastoma of paranasal sinus, nasal cavity, Recurrent inverted papilloma of the paranasal sinus, nasal cavity, Recurrent midline granuloma of the paranasal sinus, nasal cavity, Untreated, current, metastatic squamous neck cancer, Recurrent verrucous carcinoma of the larynx, Recurrent lymphoepithelioma of the oropharynx, Stage I verrucous carcinoma of the larynx, Recurrent verrucous carcinoma of the oral cavity, Stage I verrucous carcinoma of the oral cavity, Stage II verrucous carcinoma of the larynx, Stage II verrucous carcinoma of the oral cavity, Stage III verrucous carcinoma of the larynx, Stage III verrucous carcinoma of the oral cavity, Stage IV verrucous carcinoma of the larynx, Stage IV verrucous carcinoma of the oral cavity, Recurrent adenoid cystic carcinoma of the oral cavity, Stage I adenoid cystic carcinoma of the oral cavity, Stage II adenoid cystic carcinoma of the oral cavity, Stage III adenoid cystic carcinoma of the oral cavity, Stage IV adenoid cystic carcinoma of the oral cavity, Recurrent mucoepidermoid carcinoma of the oral cavity, Stage I mucoepidermoid carcinoma of the oral cavity, Stage II mucoepidermoid carcinoma of the oral cavity, Stage III mucoepidermoid carcinoma of the oral cavity, Stage IV mucoepidermoid carcinoma of the oral cavity, Recurrent squamous cell carcinoma of the lip and oral cavity, Stage I squamous cell carcinoma of the lip and oral cavity, Stage II squamous cell carcinoma of the lip and oral cavity, Stage III squamous cell carcinoma of the lip and oral cavity, Stage IV squamous cell carcinoma of the lip and oral cavity
Eligibility Criteria
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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Arm I: GM-CSF Group (GG)
Arm II: Salt & Soda Group (SS)
Arm III: Salt & Soda Switched to GM-CSF (SG)
Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.