Cox-2 Inhibition in Radiation-induced Oral Mucositis

Oral Mucositis Clinical Trial

Official title:

Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698204
• Other study ID #: IRB 03 -157- 2
• Secondary ID: GCRC 487COXAON-0
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: May 7, 2014
• Start date: July 2003
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• celecoxib
Subject was asked to take celecoxib each day that radiation therapy was given.
• placebo
Subject was asked to take placebo each day that radiation therapy was given.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut Health Center	National Institute of Dental and Craniofacial Research (NIDCR), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No