Cox-2 Inhibition in Radiation-induced Oral Mucositis
This study is ongoing, but not recruiting participants.
Sponsor:
University of Connecticut Health Center
Collaborators:
Pfizer
Information provided by (Responsible Party):
Rajesh Lalla, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00698204
First received: June 12, 2008
Last updated: September 21, 2012
Last verified: September 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis |
Resource links provided by NLM:
Further study details as provided by University of Connecticut Health Center:
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 ]
| Enrollment: | 43 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I- Celecoxib |
Drug: celecoxib
Subject will be asked to take celecoxib each day that radiation therapy is given.
Other Name: Celebrex
|
| Placebo Comparator: II |
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
Locations
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030-1605 | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
Sponsors and Collaborators
University of Connecticut Health Center
Pfizer
Investigators
| Principal Investigator: | Rajesh V Lalla, DDS, Ph.D, CCRP | University of Connecticut Health Center |
More Information
No publications provided
| Responsible Party: | Rajesh Lalla, Assistant Professor, Oral Medicine, University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT00698204 History of Changes |
| Other Study ID Numbers: | IRB 03 -157- 2, GCRC 487, COXAON-0509-150, K23DE016946-05 |
| Study First Received: | June 12, 2008 |
| Last Updated: | September 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Connecticut Health Center:
|
Mucositis Head and Neck Cancer Head and Neck Neoplasms Stomatitis |
Additional relevant MeSH terms:
|
Stomatitis Mucositis Mouth Diseases Stomatognathic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013