Cox-2 Inhibition in Radiation-Induced Oral Mucositis - Full Text View

Sponsors and Collaborators:	University of Connecticut National Institutes of Health (NIH) Pfizer
Information provided by:	University of Connecticut
ClinicalTrials.gov Identifier:	NCT00698204

Purpose

Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study will examine the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.

Condition	Intervention	Phase
Oral Mucositis	Drug: celecoxib Drug: placebo	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

Further study details as provided by University of Connecticut:

Primary Outcome Measures:

Clinical oral mucosal injury score [ Time Frame: over 6-7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain scores [ Time Frame: over 6-7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2003
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I- Celecoxib: Experimental	Drug: celecoxib Subject will be asked to take celecoxib each day that radiation therapy is given.
II: Placebo Comparator	Drug: placebo Subject will be asked to take placebo each day that radiation therapy is given.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Patients who will be receiving at least 5000 cGy radiation therapy to at least 2 of 14 pre-defined areas in the oral cavity.
Women of childbearing potential must agree to use a medically accepted form of contraception during the course of the study. Women of childbearing potential must have a documented negative pregnancy test within fourteen days of enrollment in the study.
Patient's willing and able to provide written informed consent for the study.

Key Exclusion Criteria:

Patients with known hypersensitivity to celecoxib or other COX-2 inhibitors.
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking salicylates (e.g. aspirin) or NSAIDs.
Patients who have demonstrated allergic-type reactions to sulfonamides.
Patients with a history of gastric, esophageal, pyloric channel or duodenal ulcer disease or gastrointestinal bleeding.
Patients with a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or pancreatic disease.
Patients with severe hepatic impairment.
Patients with advanced renal disease.
Patients with a significant bleeding disorder.
Patients under the age of 18 or over the age of 75.
Women who are pregnant or nursing.
Patients with a history of thromboembolic events including myocardial infarction, pulmonary embolism, deep venous thrombosis, transient ischemic attack and ischemic cerebrovascular accident (stroke).
Patients who have had coronary angioplasty, coronary artery bypass surgery or another cardiac revascularization procedure.
Patients with a history of a cardiac arrhythmia requiring anti-arrhythmic therapy, angina pectoris or congestive heart failure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698204

Contacts

Contact: Linda Choquette, RDH, CCRP

860-679-3918

choquette@uchc.edu

Locations

United States, Connecticut
University of Connecticut Health Center	Recruiting
Farmington, Connecticut, United States, 06030-1605
Sub-Investigator: Robert J Dowsett, MD
Sub-Investigator: Upendra Hegde, MD
Sub-Investigator: Carol E Pilbeam, MD
Sub-Investigator: Stephen T Sonis, DMD, DMSc
Sub-Investigator: Khamis Abu-Hasaballah, Ph.D

Sponsors and Collaborators

University of Connecticut

National Institutes of Health (NIH)

Pfizer

Investigators

Principal Investigator:	Rajesh V Lalla, DDS, Ph.D, CCRP	University of Connecticut Health Center
Principal Investigator:	Douglas E Peterson, DMD, Ph.D	University of Connecticut Health Center

More Information

Responsible Party:	University of Connecticut Health Center ( Rajesh V. Lalla, DDS, Ph.D, CCRP and Douglas E. Peterson DMD, Ph.D )
Study ID Numbers:	IRB 03 -157- 2, GCRC 487, Pfizer, Inc.: COXAON-0509-150
Study First Received:	June 12, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00698204
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Connecticut:

Mucositis
Head and Neck Cancer
Head and Neck Neoplasms
Stomatitis

Study placed in the following topic categories:

Mouth Diseases
Celecoxib
Digestive System Diseases
Stomatitis
Mucositis

Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009