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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on the oral health of patients who have dry mouth which was caused by radiation therapy that was given for treatment of head and/or neck cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Academy of Otolaryngology-Head and Neck Surgery Foundation
• Collaborator: Duke University
• Treatments: Cevimeline

Criteria

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)