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

Primary Purpose

Xerostomia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cevimeline
Sponsored by
American Academy of Otolaryngology-Head and Neck Surgery Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring dry mouth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Carle Clinic Association
  • University of Kansas Medical Center
  • Commonwealth Ear, Nose and Throat
  • Associated Otolaryngologist
  • University of Pittsburgh
  • Fauquier ENT Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cevimeline

Placebo

Arm Description

Evoxac tid for xerostomia

sugar pill

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate if increased salivary flow due to cevimeline treatment results in improved patient reported quality of life using the UW-QOL-HN
To evaluate which subscales of the OHIP-49 are improved most by increased salivary flow due to cevimeline treatment
To evaluate which subscales of the UW-QOL-HN are improved most by increased salivary flow due to cevimeline treatment

Full Information

First Posted
April 23, 2007
Last Updated
May 21, 2014
Sponsor
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00466388
Brief Title
Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia
Acronym
SMILE
Official Title
An Investigator-Initiated,Multicenter,Randomized,Double-Blind Placebo-Controlled Design Study to Assess the Effectiveness of CeviMeline to Improve OraL Health in Patients With XErostomia Secondary to Radiation Therapy for Treatment of Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Collaborators
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Treatment of advanced head and neck squamous cell carcinoma (SCCA) requires aggressive therapy often combining surgical interventions with radiation therapy. Besides surveillance for persistent or recurrent cancer, clinicians seek to help minimize the side effects resulting from these aggressive treatments. Xerostomia, or "dry mouth", impacts each patient's long term health and quality of life due to the significant and diverse health consequences of having too little saliva. Normal swallowing, speaking, resistance to infection, and taste acuity are health domains that are affected by dry mouth. Psycho-social functioning decreases for many of these patients due to the extra effort to communicate and socialize (Locker D 2004). Xerostomia is often a consequence of radiation treatment (XRT), especially when the XRT fields encompass the parotid glands and submandibular glands bilaterally. The disability and consequences of xerostomia extend beyond dysphagia, poor appetite secondary to difficulty of mastication, and loss of taste (Chambers et al. Xerostomia 2004). Since saliva is essential to normal oral flora and healthy teeth, the lack of saliva in these patients can dramatically and rapidly result in a decline of the patient's oral health. Dental complications can occur and present significant ongoing medical and surgical problems. Our study proposes to use the Oral Health Impact Profile, OHIP-49, to measure disease-specific quality of life and functional outcomes due to radiation related xerostomia in head and neck cancer patients. The evaluation of patient QOL concomitantly with patient functioning as proposed in the SMILE protocol is an "evidence study to evaluate treatment effectiveness". The use of patient-oriented outcome measures are increasingly important to health insurers and government, but these measures are also aligned with the World Health Organization's mandate that health is a resource to manage which must be utilized and preserved so that individuals experience and gain satisfaction from living (Epstein J.1986). The OHIP-49 is patient reported outcome measure which is publicly available, validated in adult populations world-wide, and can be used an effectiveness measure. The questions are easy to answer and are based upon a 5 level likert type scale reflecting frequency of "bother" within individual psychosocial domains.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
dry mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cevimeline
Arm Type
Experimental
Arm Description
Evoxac tid for xerostomia
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
Cevimeline
Other Intervention Name(s)
evoxac
Primary Outcome Measure Information:
Title
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To evaluate if increased salivary flow due to cevimeline treatment results in improved patient reported quality of life using the UW-QOL-HN
Time Frame
6 weeks
Title
To evaluate which subscales of the OHIP-49 are improved most by increased salivary flow due to cevimeline treatment
Time Frame
6 weeks
Title
To evaluate which subscales of the UW-QOL-HN are improved most by increased salivary flow due to cevimeline treatment
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Witsell, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Commonwealth Ear, Nose and Throat
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Associated Otolaryngologist
City
Palmyra
State/Province
Pennsylvania
ZIP/Postal Code
17078
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Fauquier ENT Consultants
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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