Cox-2 Inhibition in Radiation-induced Oral Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: celecoxib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I- Celecoxib<br> | Drug: celecoxib<br>* Subject was asked to take celecoxib each day that radiation therapy was given.<br>* Other names: Celebrex;|
| Placebo Comparator: II<br> | Drug: placebo<br>* Subject was asked to take placebo each day that radiation therapy was given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy | Oral Mucositis Assessment Scale (OMAS) was used to assess oral mucosal injury during the period of radiation therapy. This validated scale scores ulceration and erythema independently at nine specified sites in the oral cavity. Ulceration is scored from 0-3 based on size of lesion and erythema is scored from 0-2 based on severity of erythema. The sum of scores is then divided by 9. The mean OMAS score at a cumulative radiation dose of 5000 cGy (approximately 5 weeks of treatment) was compared between groups. | 5 weeks from start of radiation therapy (5000 cGy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pain Severity at 5000 cGy Radiation | Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable | 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucositis, Head and Neck Cancer, Head and Neck Neoplasms, Stomatitis