Cox-2 Inhibition in Radiation-induced Oral Mucositis
|ClinicalTrials.gov Identifier: NCT00698204|
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Oral Mucositis||Drug: celecoxib Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2013|
|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.
- Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy [ Time Frame: 5 weeks from start of radiation therapy (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.
- Evaluation of Pain Severity at 5000 cGy Radiation [ Time Frame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy) ]Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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||UConn Health|