• Swallowing dysfunction as measured by the modified barium swallow score, dental history and extractions, and 24-hour dietary recalls [ Designated as safety issue: Yes ]
  

• Stimulated and unstimulated salivary production [ Designated as safety issue: No ]
  
• Changes in the amounts and textures of food consumed as measured by 24-hour dietary recalls [ Designated as safety issue: No ]
  
• Mucositis as measured by CTC 3.0 [ Designated as safety issue: Yes ]
  
• Biochemical and inflammatory markers including C-reactive protein and cytokines and a marker of whole body oxidative stress [ Designated as safety issue: No ]
  
• Changes in the frequency and types of dietary intakes as measured by 24-hour dietary recalls [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine as measured using the modified barium swallow score with the Functional Communication Measure.
• To assess the ability to consume foods adequate to meet nutritional needs, particularly the ability to swallow solid foods and the continued need for liquid oral or enteral supplements as measured by 24-hour dietary recalls.

Secondary

• To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
• To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
• To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status as measured by appetite and hunger; serum biomarkers of nutritional and physical status; anthropometry; body composition including percentage of lean body mass and body fat mass; muscle strength and endurance; physical activity level; performance; functionality; and fatigue.

OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.

Patients are randomized to 1 of 2 treatment arms.

• Arm I (standard of care): Patients are further randomized to 1 of 2 treatment arms.

  • Arm IA: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
  • Arm IB: Patients undergo SNT and low weight resistance training (LWRT).

• Arm II (amifostine): Patients are further randomized to 1 of 2 treatment arms.

  • Arm IIA: Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT as in arm IA.
  • Arm IIB: Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.

Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandom mass spectrometry.

After completion of study treatment, patients are followed at 1, 3, and 6 months.