Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

Summary

Primary Objective: To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC. Secondary Objectives: 1. To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population: * When the mean dose is \< 24-26 Gy (shift recovery time to left) * When the mean dose is \> 24-26 Gy (DVH shift) 2. To observe mucositis in the following lower dose RT areas: * Upper lip * Lower lip * Right cheek * Left cheek * Right ventral and lateral tongue * Left ventral and lateral tongue * Floor of the mouth * Soft palate * Hard palate. 3. To observe the incidence and patterns of occipital scalp epilation; 4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and 5. To further evaluate the safety profile of amifostine in this patient population.

Timeline

Start

2006-12

Primary completion

2009-01

Completion

2009-01

Drugs

Indications