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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
43
University of Connecticut Health Center
Farmington, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
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.
Time frame: 5 weeks from start of radiation therapy (5000 cGy)
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
Time frame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)
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