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Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

Phase 2
18 Years
75 Years
Open (Enrolling)
Oral Mucositis

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Trial Information

Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis


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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Clinical oral mucosal injury score

Outcome Time Frame:

over 6-7 weeks

Safety Issue:


Principal Investigator

Rajesh V Lalla, DDS, Ph.D, CCRP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Connecticut Health Center


United States: Institutional Review Board

Study ID:

IRB 03 -157- 2



Start Date:

July 2003

Completion Date:

June 2013

Related Keywords:

  • Oral Mucositis
  • Mucositis
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Stomatitis
  • Stomatitis
  • Mucositis



Hartford Hospital Hartford, Connecticut  06102-5037
University of Connecticut Health Center Farmington, Connecticut  06360-7106