Cox-2 Inhibition in Radiation-induced Oral Mucositis
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Rajesh Lalla, University of Connecticut Health Center
First received: June 12, 2008
Last updated: September 21, 2012
Last verified: September 2012
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
||Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
Experimental: I- Celecoxib
Subject will be asked to take celecoxib each day that radiation therapy is given.
Other Name: Celebrex
Placebo Comparator: II
Subject will be asked to take placebo each day that radiation therapy is given.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698204
|University of Connecticut Health Center
|Farmington, Connecticut, United States, 06030-1605 |
|Hartford, Connecticut, United States, 06102 |
University of Connecticut Health Center
||Rajesh V Lalla, DDS, Ph.D, CCRP
||University of Connecticut Health Center
No publications provided
||Rajesh Lalla, Assistant Professor, Oral Medicine, University of Connecticut Health Center
History of Changes
|Other Study ID Numbers:
||IRB 03 -157- 2, GCRC 487, COXAON-0509-150, K23DE016946-05
|Study First Received:
||June 12, 2008
||September 21, 2012
||United States: Institutional Review Board
Keywords provided by University of Connecticut Health Center:
Head and Neck Cancer
Head and Neck Neoplasms
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Digestive System Diseases
Cyclooxygenase 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents