GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Condition: Head and Neck Cancer; Mucositis Oral; Radiation Toxicity; Tongue Cancer
MeSH terms: Head and Neck Neoplasms; Tongue Neoplasms; Mucositis; Stomatitis
Intervention: sargramostim; oral salt and soda mouthwash
Intervention description: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.
Intervention MeSH terms: Sargramostim
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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.
    

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