Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer; Long-term Effects Secondary to Cancer Therapy in Adults; Oral Complications of Radiation Therapy; Radiation Toxicity
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Tests that measure how much saliva is made, hearing, swallowing, voice function,
      and quality of life may improve the ability to plan treatment for patients with advanced head
      and neck cancer and may help doctors find better ways to treat the cancer.

      PURPOSE: This clinical trial is studying the side effects of high-dose intensity-modulated
      radiation therapy in treating patients with advanced head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess salivary function in patients with advanced head and neck cancer treated with
           intensity-modulated radiotherapy (IMRT) by measuring stimulated saliva production at 6
           and 12 months after completion of therapy.

        -  Compare salivary function in these patients to salivary function in historical controls.

      Secondary

        -  Assess auditory, swallow, and voice function and quality of life of these patients
           before and after IMRT or chemoradiotherapy.

        -  Advance experience with IMRT/tomotherapy and improve field design for irradiating head
           and neck cancer in an effort to reduce radiation dose and minimize effects on
           surrounding normal tissue.

      OUTLINE: This is a prospective study.

      Patients undergo standard of care high-dose intensity-modulated radiotherapy (IMRT) to the
      head and neck.

      Patients undergo baseline and post-treatment testing of auditory, salivary, swallow, and
      voice function as well as quality of life evaluation.

      Patients are evaluated for radiation-induced toxicities at 1, 6, and 12 months after
      completion of IMRT.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): adjuvant therapy; management of therapy complications; quality-of-life assessment; intensity-modulated radiation therapy
Intervention type(s): Procedure; Procedure; Procedure; Radiation
Keywords: long-term effects secondary to cancer therapy in adults; oral complications of radiation therapy; radiation toxicity; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; stage III lymphoepithelioma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV lymphoepithelioma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III basal cell carcinoma of the lip; stage III squamous cell carcinoma of the lip and oral cavity; stage IV basal cell carcinoma of the lip; stage IV squamous cell carcinoma of the lip and oral cavity; stage III adenoid cystic carcinoma of the oral cavity; stage III mucoepidermoid carcinoma of the oral cavity; stage III verrucous carcinoma of the oral cavity; stage IV adenoid cystic carcinoma of the oral cavity; stage IV mucoepidermoid carcinoma of the oral cavity; stage IV verrucous carcinoma of the oral cavity; metastatic squamous neck cancer with occult primary; stage III lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage III inverted papilloma of the paranasal sinus and nasal cavity; stage III midline lethal granuloma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage IV inverted papilloma of the paranasal sinus and nasal cavity; stage IV midline lethal granuloma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III salivary gland cancer; stage IV salivary gland cancer; recurrent salivary gland cancer; recurrent lymphoepithelioma of the nasopharynx; recurrent lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent verrucous carcinoma of the larynx; recurrent adenoid cystic carcinoma of the oral cavity; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent verrucous carcinoma of the oral cavity; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent basal cell carcinoma of the lip; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent metastatic squamous neck cancer with occult primary; untreated metastatic squamous neck cancer with occult primary