Cox-2 Inhibition in Radiation-induced Oral Mucositis
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Intervention: celecoxib; placebo
Intervention description: Subject was asked to take celecoxib each day that radiation therapy was given.; Subject was asked to take placebo each day that radiation therapy was given.
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mucositis; Head and Neck Cancer; Head and Neck Neoplasms; Stomatitis

Summary:

      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 examined the use of an
      anti-inflammatory medicine to reduce pain and severity of oral mucositis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients who will be receiving at least 5000 centigray (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 Non-steroidal anti-inflammatory drugs (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.