Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy
• •* TX, T1-4, NX, N0-3, M0
• •* Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume
• •* At least 6 cm\^2 in area irrespective of shape
• •* No M1 disease
• •Intention to deliver radiotherapy to a radical dose without chemotherapy
• •May have had surgical resection of the primary or neck nodes
• •* Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed
• •* Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed
• •PATIENT CHARACTERISTICS:
• •Age:
• •16 and over
• •Performance status:
• •ECOG 0-1
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Hemoglobin ≥ 10 g/dL
• •Granulocyte count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hepatic:
• •Not specified
• •Renal:
• •Not specified
• •Other:
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •HIV negative
• •Must have normal sleeping habits (i.e., normal circadian rhythm)
• •Must have had dental assessment and necessary prophylactic dental extractions carried out
• •No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis)
• •No organic brain syndrome related to chronic alcohol excess or other cause of sufficient severity that would preclude cooperation with treatment
• •No active uncontrolled infection
• •No history of psychiatric or neurological disorder that would preclude study compliance
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •See Disease Characteristics
• •At least 6 months since prior chemotherapy
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •See Disease Characteristics
• •No prior radiotherapy to the head and neck region
• •Surgery:
• •See Disease Characteristics
• •Other:
• •No other concurrent oral hygiene regimen other than that described in the protocol
• •No concurrent radioprotective drugs or therapy