Cox-2 Inhibition in Radiation-induced Oral Mucositis
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.
|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|
- Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy [ Time Frame: 5 weeks from start of radiation therapy (5000 cGy) ] [ Designated as safety issue: No ]
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.
- Evaluation of Pain Severity at 5000 cGy Radiation [ Time Frame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy) ] [ Designated as safety issue: No ]Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable
|Study Start Date:||July 2003|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Experimental: I- Celecoxib||
Subject was asked to take celecoxib each day that radiation therapy was given.
Other Name: Celebrex
|Placebo Comparator: II||
Subject was asked to take placebo each day that radiation therapy was given.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698204
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030-1605|
|Hartford, Connecticut, United States, 06102|
|Principal Investigator:||Rajesh V Lalla, DDS, Ph.D, CCRP||University of Connecticut Health Center|