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Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Oral Complications, Radiation Toxicity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cevimeline hydrochloride
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, oral complications, stage I squamous cell carcinoma of the lip and oral cavity, stage I basal cell carcinoma of the lip, stage I verrucous carcinoma of the oral cavity, stage I mucoepidermoid carcinoma of the oral cavity, stage I adenoid cystic carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II basal cell carcinoma of the lip, stage II verrucous carcinoma of the oral cavity, stage II mucoepidermoid carcinoma of the oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III verrucous carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage I squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage I inverted papilloma of the paranasal sinus and nasal cavity, stage I midline lethal granuloma of the paranasal sinus and nasal cavity, stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II inverted papilloma of the paranasal sinus and nasal cavity, stage II midline lethal granuloma of the paranasal sinus and nasal cavity, stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, radiation toxicity

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region Radiotherapy completed more than 4 months prior to study Clinically significant salivary gland dysfunction with grade 2 or 3 xerostomia At least 1 anatomically intact parotid gland No suspected or confirmed bilateral physical closure of salivary gland ducts No history of primary or secondary Sjogren's syndrome or other underlying systemic illness known to cause xerostomia independent of prior radiotherapy exposure PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 9.0 g/dL No anemia Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 2 times ULN Lactate dehydrogenase no greater than 2 times ULN No evidence of active liver disease Renal: Creatinine no greater than 2.5 mg/dL BUN no greater than 50 mg/dL No history of nephrolithiasis within the past 6 months Cardiovascular: No history of significant cardiovascular disease No active congestive heart failure No uncontrolled angina No significant arrhythmia No myocardial infarction within the past 6 months Pulmonary: No history of significant pulmonary disease No controlled or uncontrolled asthma No chronic bronchitis or chronic obstructive pulmonary disease that would limit avocational activities Gastrointestinal: No history of significant gastrointestinal disorder No active pancreatic disease No gastroduodenal ulcers within the past 6 months No hypersensitive bowel conditions requiring pharmacologic therapy No inflammatory bowel disease No history of cholelithiasis within the past 6 months (unless cholecystectomy performed) Other: No clinically significant laboratory abnormality No history of alcohol or drug abuse within the past 6 months that would preclude study No prior or concurrent acute iritis or narrow-angle (angle closure) glaucoma Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since other investigational new drug At least 4 weeks since prior systemic or ophthalmic pilocarpine No prior cevimeline No concurrent hyperbaric oxygen therapy No concurrent beta adrenergic antagonists, anticholinergic agents, cevimeline metabolism inhibitors, or other medications known to effect salivary function No other concurrent investigational drugs

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Mobile Infirmary Medical Center
  • Cranial Pain Research
  • University of Arkansas for Medical Sciences
  • Alta Bates Comprehensive Cancer Center
  • Jonsson Comprehensive Cancer Center, UCLA
  • Chao Family Comprehensive Cancer Center
  • Radiation Oncology Center - Sacramento
  • Rebecca and John Moores UCSD Cancer Center
  • Stanford University Medical Center
  • Colorado Otolaryngology Associates
  • University of Connecticut Health Center
  • Walter Reed Army Medical Center
  • Innovative Medical Research of South Florida, Inc.
  • Medical College of Georgia Hospital and Clinics
  • Kootenai Medical Center
  • University of Illinois at Chicago
  • University of Chicago Cancer Research Center
  • Evanston Northwestern Health Care
  • University of Kansas Medical Center
  • Central Baptist Hospital
  • James Graham Brown Cancer Center
  • Tulane Cancer Center
  • Harbor Hospital Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Dana-Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
  • University of Minnesota School of Dentistry
  • University of Mississippi Medical Center
  • University of Missouri
  • Siteman Cancer Center
  • University of Nebraska Medical Center
  • University of Nebraska Medical Center
  • Norris Cotton Cancer Center
  • Hackensack University Medical Center
  • Monmouth Medical Center
  • Professional Otolaryngology Associates
  • Albert Einstein Clinical Cancer Center
  • North Shore University Hospital
  • NYU - David B. Kriser Dental Center
  • Mount Sinai Medical Center, NY
  • James P. Wilmot Cancer Center
  • State University of New York at Stony Brook School of Medicine
  • State University of New York - Upstate Medical University
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Gaston Memorial
  • Matthews Radiation Oncology Center
  • Clinical Research of Winston Salem
  • Cleveland Clinic Taussig Cancer Center
  • Oregon Cancer Institute
  • Geisinger Medical Center
  • Head and Neck Associates
  • Associated Otolaryngologist
  • University of Pennsylvania Cancer Center
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  • Eye and Ear Institute
  • Medical University of South Carolina
  • Memorial Hospital Cancer Center - Chattanooga
  • MultiSpecialty Clinical Research
  • Dial Research Associates, Inc.
  • Vanderbilt-Ingram Cancer Center
  • Baylor College of Dentistry
  • University of Texas - MD Anderson Cancer Center
  • Cancer Physicians Associates, PA
  • Latter Day Saints Hospital
  • Seattle Institute for Biomedical and Clinical Research
  • Madigan Army Medical Center
  • Southwest Washington Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00017511
Brief Title
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Official Title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cevimeline in the Treatment of Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.
Detailed Description
OBJECTIVES: Compare the efficacy of cevimeline vs placebo, in terms of dryness of the oral cavity and salivary flow, in patients with xerostomia secondary to radiotherapy for cancers in the head and neck region. Assess the safety of this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral cevimeline 3 times daily for 12 weeks in the absence of unacceptable toxicity. Arm II: Patients receive oral placebo as in arm I. PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oral Complications, Radiation Toxicity
Keywords
stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, oral complications, stage I squamous cell carcinoma of the lip and oral cavity, stage I basal cell carcinoma of the lip, stage I verrucous carcinoma of the oral cavity, stage I mucoepidermoid carcinoma of the oral cavity, stage I adenoid cystic carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II basal cell carcinoma of the lip, stage II verrucous carcinoma of the oral cavity, stage II mucoepidermoid carcinoma of the oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III verrucous carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage I squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage I inverted papilloma of the paranasal sinus and nasal cavity, stage I midline lethal granuloma of the paranasal sinus and nasal cavity, stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II inverted papilloma of the paranasal sinus and nasal cavity, stage II midline lethal granuloma of the paranasal sinus and nasal cavity, stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, radiation toxicity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cevimeline hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region Radiotherapy completed more than 4 months prior to study Clinically significant salivary gland dysfunction with grade 2 or 3 xerostomia At least 1 anatomically intact parotid gland No suspected or confirmed bilateral physical closure of salivary gland ducts No history of primary or secondary Sjogren's syndrome or other underlying systemic illness known to cause xerostomia independent of prior radiotherapy exposure PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 9.0 g/dL No anemia Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 2 times ULN Lactate dehydrogenase no greater than 2 times ULN No evidence of active liver disease Renal: Creatinine no greater than 2.5 mg/dL BUN no greater than 50 mg/dL No history of nephrolithiasis within the past 6 months Cardiovascular: No history of significant cardiovascular disease No active congestive heart failure No uncontrolled angina No significant arrhythmia No myocardial infarction within the past 6 months Pulmonary: No history of significant pulmonary disease No controlled or uncontrolled asthma No chronic bronchitis or chronic obstructive pulmonary disease that would limit avocational activities Gastrointestinal: No history of significant gastrointestinal disorder No active pancreatic disease No gastroduodenal ulcers within the past 6 months No hypersensitive bowel conditions requiring pharmacologic therapy No inflammatory bowel disease No history of cholelithiasis within the past 6 months (unless cholecystectomy performed) Other: No clinically significant laboratory abnormality No history of alcohol or drug abuse within the past 6 months that would preclude study No prior or concurrent acute iritis or narrow-angle (angle closure) glaucoma Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since other investigational new drug At least 4 weeks since prior systemic or ophthalmic pilocarpine No prior cevimeline No concurrent hyperbaric oxygen therapy No concurrent beta adrenergic antagonists, anticholinergic agents, cevimeline metabolism inhibitors, or other medications known to effect salivary function No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Vitti, MD
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Cranial Pain Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-7199
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Radiation Oncology Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8757
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
Colorado Otolaryngology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-7106
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Facility Name
Medical College of Georgia Hospital and Clinics
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Kootenai Medical Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7317
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7321
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3267
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215-1290
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0910
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota School of Dentistry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
University of Nebraska Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-1225
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Professional Otolaryngology Associates
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU - David B. Kriser Dental Center
City
New York
State/Province
New York
ZIP/Postal Code
10010-4086
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State University of New York at Stony Brook School of Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8706
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Gaston Memorial
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28053-1747
Country
United States
Facility Name
Matthews Radiation Oncology Center
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Clinical Research of Winston Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-1333
Country
United States
Facility Name
Head and Neck Associates
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Facility Name
Associated Otolaryngologist
City
Palmyra
State/Province
Pennsylvania
ZIP/Postal Code
17078
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Eye and Ear Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Memorial Hospital Cancer Center - Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
MultiSpecialty Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Dial Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5671
Country
United States
Facility Name
Baylor College of Dentistry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cancer Physicians Associates, PA
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Latter Day Saints Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Facility Name
Seattle Institute for Biomedical and Clinical Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Southwest Washington Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States

12. IPD Sharing Statement

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Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer

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