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

NCT00466388 | Completed Phase 4

• 1 other identifier: AAO-101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Xerostomia

Keywords

dry mouth

Outcome Measures

Primary Outcomes (1)

• To assess the impact of increased salivary flow due to treatment with cevimeline compared to placebo in patient reported oral health using the OHIP-49

  6 weeks

Secondary Outcomes (3)

• To evaluate if increased salivary flow due to cevimeline treatment results in improved patient reported quality of life using the UW-QOL-HN

  6 weeks

• To evaluate which subscales of the OHIP-49 are improved most by increased salivary flow due to cevimeline treatment

  6 weeks

• To evaluate which subscales of the UW-QOL-HN are improved most by increased salivary flow due to cevimeline treatment

  6 weeks

Study Arms (2)

Cevimeline

EXPERIMENTAL

Evoxac tid for xerostomia

Drug: Cevimeline

Placebo

PLACEBO COMPARATOR

sugar pill

Drug: Cevimeline

Interventions

Cevimeline DRUG

Also known as: evoxac

Cevimeline; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Academy of Otolaryngology-Head and Neck Surgery Foundation: lead
• Duke University: collaborator

Study Sites (7)

Unknown Facility

Colorado Springs, Colorado, United States

Location

Carle Clinic Association

Urbana, Illinois, 61801, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Commonwealth Ear, Nose and Throat

Louisville, Kentucky, 40207, United States

Location

Associated Otolaryngologist

Palmyra, Pennsylvania, 17078, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Fauquier ENT Consultants

Warrenton, Virginia, 20186, United States

Location

MeSH Terms

Conditions

Xerostomia

Interventions

cevimeline

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• David Witsell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (7)