Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia

Inclusion Criteria:

* Subject is at least 18 years old and able to give written informed consent
* Subject has received external beam radiotherapy \> 4000 cGy for SCCA of the head and/or neck
* Radiation therapy was completed at least 16 weeks (4 months) prior to enrollment into the study but not greater than 52 weeks (12 months)
* Radiation included at least three of four of the major salivary glands (submandibular and parotid glands) in the initial field (boost fields may or may not include the parotid gland)
* Primary therapy was designed with curative intent. Surgery is permitted if the remaining inclusion criteria are met
* Grade 1 or 2 xerostomia by CTC version 3.0 criteria (Appendix D)
* Demonstratable salivary flow as assessed by the clinician after administration of a potent sialogogue such as lemon juice (1 teaspoon)
* Subject has at least one anatomically intact parotid gland and one submandibular gland
* ECOG performance status of 0, 1, or 2
* An EKG obtained has been performed in the past 6 months showing no arrhythmias or contraindication to administration of a muscarinic agent AND there has been no interval change in cardiac health
* Subject is able to eat an oral diet to maintain adequate hydration and nutrition
* Subject has provided informed consent
* Subject is English speaking and of sufficient mental capacity to comply with the study requirements
* Female subjects of child bearing potential have a negative serum pregnancy test and agree to use an approved method of birth control

Exclusion Criteria:

* Subject has a life expectancy less than 12 months.
* Subject is known or suspected to have persistent disease after curative intent
* Subject is greater than 12 months out from completion of radiation therapy
* Subject is pregnant or nursing
* Subject had previous cancer of the head and/or neck and is being treated with a second course of radiation therapy
* Subject has a history of an autoimmune disease with pretreatment xerostomia (i.e. Sjogrens) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure
* Subject has had resection of both parotid glands
* Subject has history of cardiomyopathy or untreated moderate to severe CAD
* Subject has known cardiac arrhythmias
* Subject has grade 3 xerostomia (CTC v.3)or no demonstratable salivary flow after the test dose by visual inspection
* Subject has history of significant renal or hepatic impairment
* Subject uses a gastrostomy tube for nutrition supplementation
* Subject is taking medications specified in Appendix C
* Subject is taking or has taken any investigational new drug within the last 30 days or is planning to take such a drug during the course of this study
* Subject has a contraindication to administration of muscarinic medications.
* Subject has been treated previously with a muscarinic agent for xerostomia (i.e., Pilocarpine HCl)