Trial Information

Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia

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

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

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 divided into 1A or 1B.

- Arm IA: Standard of care plus standardized nutrition therapy (SNT)

- Arm IB: Standard of care plus standardized nutrition therapy plus low weight
resistance training (LWRT).

- Arm II (amifostine): Patients are further divided into 2A or 2B.

- Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each
radiation dose plus standardized nutrition therapy

- Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each
radiation dose plus standardized nutrition therapy plus low weight resistance
training

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 tandem mass spectrometry.

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