Clinical trial NCT00698204: Cox-2 Inhibition in Radiation-induced Oral Mucositis
Official title: Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: Mucositis
Head and Neck Cancer
Head and Neck Neoplasms
Stomatitis
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Pfizer
First posted: 2008-06-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy
timeFrame: 5 weeks from start of radiation therapy (5000 cGy)
Secondary outcomes:
measure: Evaluation of Pain Severity at 5000 cGy Radiation
timeFrame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: UConn Health
name: Rajesh V Lalla, DDS, Ph.D, CCRP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lalla RV, Choquette LE, Curley KF, Dowsett RJ, Feinn RS, Hegde UP, Pilbeam CC, Salner AL, Sonis ST, Peterson DE. Randomized double-blind placebo-controlled trial of celecoxib for oral mucositis in patients receiving radiation therapy for head and neck cancer. Oral Oncol. 2014 Nov;50(11):1098-103. doi: 10.1016/j.oraloncology.2014.08.001. Epub 2014 Aug 21.